Maternal & Newborn Atlas
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INVU by Nuvo (maternal-fetal monitoring belt)

A belt with sensors, worn on the abdomen, that shows the baby's heart rate, the mother's heart rate and contractions. FDA cleared it in 2021 for pregnant women in their 32nd week of gestation (or later) with a single baby, for use in a clinic or by the woman at home when a doctor orders it, for the kind of heart-rate check done before labour (a non-stress test). A device named PregSense (2020), which the FDA 2021 summary for INVU points to for heart-rate performance, was cleared for a five-minute heart-rate recording only. The FDA wording does not name use during labour, and the labelling states the system does not prevent early labour or early birth.

Also called INVU · Invu by Nuvo

  • Product
  • In this atlas

Overview

Technical summary

Three 510(k) clearances (K191401 is filed here only because the K210025 summary says INVU's heart-rate performance was addressed in it; no FDA document read calls PregSense an earlier name of INVU): K191401 (PregSense, 2020-03-27: fetal and maternal heart rate, five-minute use, antepartum, singleton, 32nd week or later, not for non-stress testing, not for labour or suspected preterm labour), K210025 (INVU by Nuvo, 2021-05-28: adds uterine activity and antepartum fetal surveillance including non-stress testing; prescription, physician order, facility or home) and K221046 (Invu by Nuvo, 2022-05-06: Special 510(k) for sensor-band material and software changes, same indication). The labelling states the system does not prevent preterm labour or preterm birth. In the K210025 uterine-activity study INVU agreed with the intrauterine catheter more often than a tocodynamometer did (84.80% against 37.50%) but had a higher false positive rate (24.28% against 10.69%). The FDA text does not use the word remote.

Product details

Type
Device
Model or formulation
INVU Sensor Band and the INVU by Nuvo maternal-fetal monitor with mobile and web software, as named in the FDA indications for use
Version
Clearances filed here: INVU by Nuvo (K210025, 2021), Invu by Nuvo (K221046, 2022) and, because the K210025 summary points to it for heart-rate performance, PregSense (K191401, 2020). US labelling only.

Intended-use sources

  1. Background FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

    Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2020-03-27
    Source state
    Current
    Snapshot hash
    9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
    Reuse basis
    The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

  2. Background FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

    Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2021-05-28
    Source state
    Current
    Snapshot hash
    4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
    Reuse basis
    The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

  3. Background FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

    Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2022-05-06
    Source state
    Current
    Snapshot hash
    3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
    Reuse basis
    The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

Claims and evidence

Context Pregnant women aged 18 to 50 years with at least 32 weeks of gestation, uterine activity validation study (INVU, K210025)

Recipient
Maternal
Population
Pregnant women aged 18 to 50 years with at least 32 weeks of gestation, in a pivotal study that recorded uterine activity with INVU, with the intrauterine pressure catheter (IUPC, called the gold standard in the summary) and with a tocodynamometer (TOCO, called the standard of care). The measured quantity, uterine contractions, belongs to the mother.
Care setting
Clinical study described in an FDA 510(k) summary; setting not described in the parts read
Geography
Not stated in the summary
Life stage
Pregnancy, at least 32 weeks of gestation (the summary writes populations of pregnant women ages between 18-50 of at least 32 weeks gestation)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Training phase of 40 and validation phase of 80 (N as the summary writes it)
Eligibility: inclusion criteria not stated; 1 exclusion criterion
Included
None stated
Excluded
  • Not stated in the parts of the source that were read.

  • Description Observational Certainty not assessed

    The 510(k) summary for K210025 describes a pivotal study of uterine activity in two phases, a training phase (N=40) and a validation phase (N=80). INVU met the performance goal that the lower 95% bound of the positive percent agreement exceed 75%, with a positive percent agreement of 84.80% (95% CI 81.58% to 88.02%) against the intrauterine pressure catheter (IUPC), which the summary calls the gold standard, compared with 37.50% (95% CI 28.23% to 46.77%) for the tocodynamometer (TOCO), the standard of care. INVU had the higher false positive rate against IUPC: 24.28% (95% CI 20.46% to 28.11%) against 10.69% (95% CI 5.65% to 15.72%) for TOCO. The summary concludes that INVU is comparable to the standard of care TOCO device and meets the required accuracy for its intended use in pregnant women aged 18 to 50 of at least 32 weeks of gestation.

    Applies to Maternal
    • Pregnant women aged 18 to 50 years with at least 32 weeks of gestation, in a pivotal study that recorded uterine activity with INVU, with the intrauterine pressure catheter (IUPC, called the gold standard in the summary) and with a tocodynamometer (TOCO, called the standard of care). The measured quantity, uterine contractions, belongs to the mother.
    • Clinical study described in an FDA 510(k) summary; setting not described in the parts read
    • Not stated in the summary
    • Pregnancy, at least 32 weeks of gestation (the summary writes populations of pregnant women ages between 18-50 of at least 32 weeks gestation)
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Training phase of 40 and validation phase of 80 (N as the summary writes it)
    Certainty method
    Not assessed
    Limitations
    This is the manufacturer's submission summary as released by FDA, not a published trial, and it reports one uterine-activity study. The false positive rate of INVU was higher than that of TOCO, and the summary does not explain what a false positive means in practice. Agreement with a catheter is not the same as an effect on outcomes. The summary says the performance for fetal and maternal heart rate was addressed in K191401, and this record does not report those figures. Only the summary pages read were used.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 2, sentence 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    2. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    3. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 4
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    4. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 5, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    5. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 5, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    6. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 6, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    7. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    8. Background FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 4, sentence 6, fragment 1 of 2
      How it applies
      Frames the population or setting. FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

Context Pregnant women in their 32nd week or later with a singleton pregnancy who need documentation of fetal heart rate, five-minute antepartum recording (US labelling of K191401)

Recipient
Mixed recipients
Population
Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later) who need documentation of fetal heart rate activity. The device shows fetal and maternal heart rate. Not for critical care, labouring patients or those hospitalised for or suspected to have preterm labour, and not for antepartum monitoring such as non-stress testing.
Care setting
Health care facilities, or the patient's home on the order of a physician
Geography
United States (FDA labelling)
Life stage
Antepartum period, 32nd week of gestation or later (the FDA summary elsewhere writes more than 32 weeks)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable; this is the cleared indication for use
Eligibility: 3 inclusion criteria; 3 exclusion criteria
Included
  • Singleton pregnancy
  • 32nd week of gestation or later
  • Needs documentation of fetal heart rate activity
Excluded
  • Critical care situations
  • Laboring patients
  • Patients hospitalized for or suspected to have preterm labor

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared PregSense (Nuvo-Group Ltd) under 510(k) K191401 on 2020-03-27. The K210025 summary for INVU by Nuvo says INVU's heart-rate performance was addressed in K191401. The cleared use is as a maternal-fetal monitor that measures and displays fetal and maternal heart rate, for pregnant women who need documentation of fetal heart rate activity and are in their 32nd week of gestation (or later) with a singleton pregnancy, for a maximum of five minutes, in the antepartum period, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician. It is not intended for critical care, for labouring patients or patients hospitalised for or suspected to have preterm labour, or for antepartum monitoring such as non-stress testing.

    Applies to Mixed recipients
    • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later) who need documentation of fetal heart rate activity. The device shows fetal and maternal heart rate. Not for critical care, labouring patients or those hospitalised for or suspected to have preterm labour, and not for antepartum monitoring such as non-stress testing.
    • Health care facilities, or the patient's home on the order of a physician
    • United States (FDA labelling)
    • Antepartum period, 32nd week of gestation or later (the FDA summary elsewhere writes more than 32 weeks)
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable; this is the cleared indication for use
    Certainty method
    Not assessed
    Limitations
    Clearance is not approval. PregSense is filed under the INVU product only because of one sentence in FDA's K210025 summary, which says INVU's heart-rate performance was addressed in K191401; no FDA document read says that PregSense is an earlier name of INVU, and this record does not show that the two are identical. This clearance does not cover uterine activity or non-stress testing. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (16)

    1. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Clearance letter, page 1, reference block
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    2. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 1
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    3. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 2, fragment 1 of 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    4. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 2, fragment 2 of 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    5. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 2, fragment 3 of 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    6. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 3, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    7. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 3, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    8. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 4, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    9. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 4, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    10. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      Indications for Use form, paragraph 5
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2020-03-27
      Source state
      Current
      Snapshot hash
      9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    11. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      results[0].decision_date
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    12. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      results[0].decision_description
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    13. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      results[0].product_code
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    14. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      results[0].openfda.regulation_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    15. Supports FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2020-03-27 · 510(k): K191401

      Locator
      results[0].k_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    16. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 1
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

Context Pregnant women in their 32nd week or later with a singleton pregnancy, antepartum surveillance (non-stress testing), hospital or home on physician order (US labelling of K210025 and K221046)

Recipient
Mixed recipients
Population
Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.
Care setting
Health care facilities, or the patient's home on the order of a physician
Geography
United States (FDA labelling)
Life stage
Antepartum period, 32nd week of gestation or later
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable; this is the cleared indication for use
Eligibility: 2 inclusion criteria; 1 exclusion criterion
Included
  • Singleton pregnancy
  • 32nd week of gestation or later
Excluded
  • Not stated in the parts of the source that were read.

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared INVU by Nuvo (Nuvo-Group Ltd) under 510(k) K210025 on 2021-05-28 as a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity. It is indicated for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, for use by healthcare professionals in health care facilities and by the patient at home, on the order of a physician, and for antepartum fetal surveillance (non-stress testing). The labelling states that the system does not prevent the onset of preterm labour and will not prevent preterm birth.

    Applies to Mixed recipients
    • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.
    • Health care facilities, or the patient's home on the order of a physician
    • United States (FDA labelling)
    • Antepartum period, 32nd week of gestation or later
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable; this is the cleared indication for use
    Certainty method
    Not assessed
    Limitations
    Clearance is not approval. The cleared use is antepartum surveillance on a physician's order; the FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Prescription use is on the order of a physician. The summary says the fetal and maternal heart rate performance was addressed in the earlier K191401, and the new clinical data it describes concern uterine activity (see the performance claim). The text for singleton pregnancies reads 32nd week of gestation (or later) in the indication and at least 32 gestational weeks or greater than 32 weeks in the comparison text; the bound is not turned into days here. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (14)

    1. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Clearance letter, page 1, reference block
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    2. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 1, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    3. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 1, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    4. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    5. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 4, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    6. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 4, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    7. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 5
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    8. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      Indications for Use form, paragraph 6
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    9. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      510(k) Summary, Clinical Performance Data, paragraph 1
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2021-05-28
      Source state
      Current
      Snapshot hash
      4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    10. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      results[0].decision_date
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    11. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      results[0].decision_description
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    12. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      results[0].product_code
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    13. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      results[0].openfda.regulation_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    14. Supports FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2021-05-28 · 510(k): K210025

      Locator
      results[0].k_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared Invu by Nuvo (Nuvo-Group Ltd) under Special 510(k) K221046 on 2022-05-06. The indication for use is worded as in K210025: a maternal-fetal monitor that measures and displays fetal heart rate, maternal heart rate and uterine activity, for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician, indicated for antepartum fetal surveillance (non-stress testing), and the labelling states it does not prevent preterm labour or preterm birth. The summary describes changes to the sensor band (material of manufacture, buckles, belt material, band length, and the charging LED) and states that no modifications affect sensor position or performance.

    Applies to Mixed recipients
    • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.
    • Health care facilities, or the patient's home on the order of a physician
    • United States (FDA labelling)
    • Antepartum period, 32nd week of gestation or later
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable; this is the cleared indication for use
    Certainty method
    Not assessed
    Limitations
    This is a Special 510(k) for changes to a device already cleared under K210025, with no new indication. Clearance is not approval. The FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (17)

    1. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Clearance letter, page 1, reference block
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    2. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 1, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    3. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 1, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    4. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    5. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 4, fragment 1 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    6. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 4, fragment 2 of 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    7. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 5
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    8. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      Indications for Use form, paragraph 6
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    9. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      510(k) Summary, Substantial Equivalence, paragraph 3, sentence 1
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    10. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      510(k) Summary, Substantial Equivalence, paragraph 3, sentence 3
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    11. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      510(k) Summary, Substantial Equivalence, paragraph 3, sentence 2
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2022-05-06
      Source state
      Current
      Snapshot hash
      3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    12. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].decision_date
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    13. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].decision_description
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    14. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].product_code
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    15. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].openfda.regulation_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    16. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].k_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

    17. Supports FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary. · Published 2022-05-06 · 510(k): K221046

      Locator
      results[0].clearance_type
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb
      Reuse basis
      The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).

Authorization

Regulatory decision: INVU by Nuvo (maternal-fetal monitoring belt)

Applies to Mixed recipients
  • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later) who need documentation of fetal heart rate activity. The device shows fetal and maternal heart rate. Not for critical care, labouring patients or those hospitalised for or suspected to have preterm labour, and not for antepartum monitoring such as non-stress testing.
  • Health care facilities, or the patient's home on the order of a physician
  • United States (FDA labelling)
  • Antepartum period, 32nd week of gestation or later (the FDA summary elsewhere writes more than 32 weeks)
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable; this is the cleared indication for use
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K191401
Product code
LQK
Device class
Class II
Jurisdictions
United States; note: United States
Product version
PregSense, as cleared under K191401
Indication
A maternal-fetal monitor that non-invasively measures and displays fetal and maternal heart rate, indicated for pregnant women who need documentation of fetal heart rate activity, in their 32nd week of gestation (or later), with a singleton pregnancy, for a maximum of five minutes, in the antepartum period. Not intended for critical care, laboring patients or patients hospitalized for or suspected to have preterm labor, and not for antepartum monitoring such as non-stress testing.
Basis
FDA cleared PregSense (Nuvo-Group Ltd) under 510(k) K191401 on 2020-03-27. The K210025 summary for INVU by Nuvo says INVU's heart-rate performance was addressed in K191401. The cleared use is as a maternal-fetal monitor that measures and displays fetal and maternal heart rate, for pregnant women who need documentation of fetal heart rate activity and are in their 32nd week of gestation (or later) with a singleton pregnancy, for a maximum of five minutes, in the antepartum period, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician. It is not intended for critical care, for labouring patients or patients hospitalised for or suspected to have preterm labour, or for antepartum monitoring such as non-stress testing.

Limitations. Clearance is not approval. PregSense is filed under the INVU product only because of one sentence in FDA's K210025 summary, which says INVU's heart-rate performance was addressed in K191401; no FDA document read says that PregSense is an earlier name of INVU, and this record does not show that the two are identical. This clearance does not cover uterine activity or non-stress testing. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Regulatory decision: INVU by Nuvo (maternal-fetal monitoring belt)

Applies to Mixed recipients
  • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.
  • Health care facilities, or the patient's home on the order of a physician
  • United States (FDA labelling)
  • Antepartum period, 32nd week of gestation or later
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable; this is the cleared indication for use
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K210025
Product code
LQK
Device class
Class II
Jurisdictions
United States; note: United States
Product version
INVU by Nuvo, as cleared under K210025
Indication
A maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity, indicated for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, for use by healthcare professionals in health care facilities and by the patient at home on the order of a physician, and for antepartum fetal surveillance (non-stress testing). The system does not prevent the onset of preterm labor nor will it prevent preterm birth.
Basis
FDA cleared INVU by Nuvo (Nuvo-Group Ltd) under 510(k) K210025 on 2021-05-28 as a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity. It is indicated for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, for use by healthcare professionals in health care facilities and by the patient at home, on the order of a physician, and for antepartum fetal surveillance (non-stress testing). The labelling states that the system does not prevent the onset of preterm labour and will not prevent preterm birth.

Limitations. Clearance is not approval. The cleared use is antepartum surveillance on a physician's order; the FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Prescription use is on the order of a physician. The summary says the fetal and maternal heart rate performance was addressed in the earlier K191401, and the new clinical data it describes concern uterine activity (see the performance claim). The text for singleton pregnancies reads 32nd week of gestation (or later) in the indication and at least 32 gestational weeks or greater than 32 weeks in the comparison text; the bound is not turned into days here. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Regulatory decision: INVU by Nuvo (maternal-fetal monitoring belt)

Applies to Mixed recipients
  • Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.
  • Health care facilities, or the patient's home on the order of a physician
  • United States (FDA labelling)
  • Antepartum period, 32nd week of gestation or later
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable; this is the cleared indication for use
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K221046
Product code
LQK
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Invu by Nuvo, as cleared under Special 510(k) K221046
Indication
The same indication as K210025: a maternal-fetal monitor that measures and displays fetal heart rate, maternal heart rate and uterine activity, for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, in health care facilities or at home on the order of a physician, for antepartum fetal surveillance (non-stress testing). The cleared changes concern the sensor band, accessories and software.
Basis
FDA cleared Invu by Nuvo (Nuvo-Group Ltd) under Special 510(k) K221046 on 2022-05-06. The indication for use is worded as in K210025: a maternal-fetal monitor that measures and displays fetal heart rate, maternal heart rate and uterine activity, for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician, indicated for antepartum fetal surveillance (non-stress testing), and the labelling states it does not prevent preterm labour or preterm birth. The summary describes changes to the sensor band (material of manufacture, buckles, belt material, band length, and the charging LED) and states that no modifications affect sensor position or performance.

Limitations. This is a Special 510(k) for changes to a device already cleared under K210025, with no new indication. Clearance is not approval. The FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
maternal:invu-remote-monitoring
Content hash
4b163ffc9e9ca261b735e720bcdc20e7a282aaffcf8841f422addd2759279855