Maternal & Newborn Atlas
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Novii wireless patch system (fetal heart rate from the abdomen)

A wireless pod and patch of electrodes stuck to the mother's abdomen that shows the baby's heart rate, the mother's heart rate and contractions without belts. FDA cleared the first version in 2014 for women in labour at more than 36 completed weeks with a single baby, and cleared Novii+ in 2023 for use before and during labour in women with a single baby at 34 weeks and 0/7 days or later, in a clinical setting. Both are described as for healthcare professionals in a clinical setting; the FDA text does not mention use at home.

  • Product
  • In this atlas

Overview

Technical summary

Two 510(k) clearances (substantial equivalence, not approval): K140862 (Monica Novii Wireless Patch System, Monica Healthcare, decision 2014-08-27, intrapartum, more than 36 completed weeks, singleton) and K231964 (Novii+ Wireless Patch System, Datex Ohmeda, decision 2023-12-08, antepartum and intrapartum, 34 weeks and 0/7 days and greater, singleton). K231964 names K140862 as its predicate. The product code differs between FDA's K140862 letter (HGM) and the openFDA record (OSP); both are shown on the decision. Clinical data summarised by FDA: 31 patients in labour (K140862) and 30 subjects at 34+0 to 36+6 weeks (K231964).

Product details

Type
Device
Model or formulation
Novii Pod with Novii Patch (surface electrodes) and Novii Interface, as named in the FDA indications for use; the later version is Novii+
Version
Cleared versions: Monica Novii Wireless Patch System (K140862, 2014) and Novii+ Wireless Patch System (K231964, 2023). US labelling only.

Intended-use sources

  1. Background FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2014-08-27
    Source state
    Current
    Snapshot hash
    40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
    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-k140862.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

    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 2023-12-08 · 510(k): K231964

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2023-12-08
    Source state
    Current
    Snapshot hash
    7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
    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-k231964.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 Women at 34 weeks 0 days or later with a singleton pregnancy, antepartum or intrapartum, monitored in a clinical setting (US labelling of K231964)

Recipient
Mixed recipients
Population
Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
Care setting
Clinical setting, used by healthcare professionals
Geography
United States (FDA labelling)
Life stage
Antepartum and intrapartum, from 34 weeks 0 days of gestation
Gestational age
at least 34 weeks 0 days (238 days), measured at the time of measurement
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
  • 34 weeks and 0/7 days of gestation or greater
Excluded
  • Not stated in the parts of the source that were read.

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared the Novii+ Wireless Patch System (Datex Ohmeda) under 510(k) K231964 on 2023-12-08. The cleared use is as an antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at 34 weeks and 0/7 days and greater with singleton pregnancies, used by healthcare professionals in a clinical setting. The 510(k) summary names the Monica Novii Wireless Patch system (K140862) as its predicate device.

    Applies to Mixed recipients
    • Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
    • Clinical setting, used by healthcare professionals
    • United States (FDA labelling)
    • Antepartum and intrapartum, from 34 weeks 0 days of gestation
    • Gestational age at least 34 weeks 0 days, measured at the time of measurement
    • Postnatal age Not reported
    Follow-up Not applicable; this is the cleared indication for use
    Certainty method
    Not assessed
    Limitations
    Clearance means FDA found the device substantially equivalent to a predicate; it is not an approval. The indication names a clinical setting and healthcare professionals; it does not name use at home. The clinical study described in the summary enrolled 30 subjects between 34+0 and 36+6 weeks (see the performance claim). 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 (10)

    1. Supports FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Indications for Use, 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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Indications for Use, 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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Indications for Use, last paragraph
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, predicate device row
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      results[0].decision_date
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      results[0].decision_description
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      results[0].product_code
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      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
      68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      results[0].k_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6
      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-k231964.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 Women at 34 weeks 0 days to 36 weeks 6 days, threatened preterm labour or preterm labour and delivery (Novii+ clinical study in K231964)

Recipient
Mixed recipients
Population
30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days of gestation: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. Compared against Doppler fetal heart rate, tocodynamometer uterine activity and pulse-oximeter maternal heart rate.
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, 34 weeks 0 days to 36 weeks 6 days
Gestational age
34 weeks 0 days (238 days) to 36 weeks 6 days (258 days), measured at enrolment
Postnatal age
Not reported
Follow-up
Not stated in the parts read
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 Novii+ (K231964) describes a clinical study of 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. The mean percent agreement for fetal heart rate between Novii+ and the predicate Doppler fetal heart rate was 88.08%, with a 95% lower confidence limit of 83.45%, above the 80% threshold set to demonstrate equivalence.

    Applies to Mixed recipients
    • 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days of gestation: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. Compared against Doppler fetal heart rate, tocodynamometer uterine activity and pulse-oximeter maternal heart rate.
    • Clinical study described in an FDA 510(k) summary; setting not described in the parts read
    • Not stated in the summary
    • Pregnancy, 34 weeks 0 days to 36 weeks 6 days
    • Gestational age 34 weeks 0 days to 36 weeks 6 days, measured at enrolment
    • Postnatal age Not reported
    Follow-up Not stated in the parts read
    Certainty method
    Not assessed
    Limitations
    This is the manufacturer's submission summary as released by FDA, not a published trial. The summary reports similar agreement tests for maternal heart rate and uterine activity that this record does not repeat. The study covers 34+0 to 36+6 weeks only, and 30 subjects. Percent agreement is not the same as clinical outcome benefit. Only the summary pages read were used.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Summary of Clinical testing, 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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Summary of Clinical testing, paragraph 3, sentence 1 continued
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Summary of Clinical testing, FHR, 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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 K231964, Novii+ Wireless Patch System (Datex Ohmeda)

      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 2023-12-08 · 510(k): K231964

      Locator
      510(k) Summary, Summary of Clinical testing, FHR, 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
      2023-12-08
      Source state
      Current
      Snapshot hash
      7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a
      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-k231964.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 Women in labour with a singleton pregnancy at more than 36 completed weeks, monitored by healthcare professionals in a clinical setting (US labelling of K140862)

Recipient
Mixed recipients
Population
Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
Care setting
Clinical setting, used by healthcare professionals
Geography
United States (FDA labelling)
Life stage
Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable; this is the cleared indication for use
Eligibility: 3 inclusion criteria; 1 exclusion criterion
Included
  • In labour
  • Singleton pregnancy
  • More than 36 completed weeks of gestation
Excluded
  • Not stated in the parts of the source that were read.

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared the Monica Novii Wireless Patch System (Monica Healthcare Ltd) under 510(k) K140862 on 2014-08-27. The cleared use is as an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at more than 36 completed weeks, in labour, with singleton pregnancies, used by healthcare professionals in a clinical setting. The indication names intrapartum use in a clinical setting; it does not name antepartum use or use at home.

    Applies to Mixed recipients
    • Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
    • Clinical setting, used by healthcare professionals
    • United States (FDA labelling)
    • Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated)
    • 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 means FDA found the device substantially equivalent to earlier devices; it is not an approval and not a recommendation to use the device for any one woman. The sources disagree on the product code: FDA's clearance letter gives HGM (21 CFR 884.2740, class II), while the openFDA record gives OSP (21 CFR 884.2720). Both are shown and are not reconciled here; the decision records the letter's code. The 510(k) summary describes a comparison with the predicate monitor in 31 patients in labour; this record gives no accuracy numbers. 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 (12)

    1. Supports FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      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
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      Indications for Use statement, paragraph 1, sentence 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
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      Indications for Use statement, paragraph 1, sentence 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
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      Indications for Use statement, paragraph 1, 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
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      Indications for Use statement, 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
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      510(k) Summary, Clinical Testing
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      510(k) Summary, Clinical Testing, paragraph 2, sentence 1 continued
      How it applies
      FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.
      Retrieved
      Source effective date
      2014-08-27
      Source state
      Current
      Snapshot hash
      40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      results[0].decision_date
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      results[0].decision_description
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa
      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-k140862.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 K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      results[0].k_number
      How it applies
      openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa
      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-k140862.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. Background FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      results[0].product_code
      How it applies
      Frames the population or setting. openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa
      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-k140862.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. Background FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare 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 2014-08-27 · 510(k): K140862

      Locator
      results[0].openfda.regulation_number
      How it applies
      Frames the population or setting. openFDA 510(k) record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa
      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-k140862.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: Novii wireless patch system (fetal heart rate from the abdomen)

Applies to Mixed recipients
  • Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
  • Clinical setting, used by healthcare professionals
  • United States (FDA labelling)
  • Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated)
  • 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
K140862
Product code
HGM
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Monica Novii Wireless Patch System, as cleared under K140862
Indication
An intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at more than 36 completed weeks, in labour, with singleton pregnancies, for use by healthcare professionals in a clinical setting.
Basis
FDA cleared the Monica Novii Wireless Patch System (Monica Healthcare Ltd) under 510(k) K140862 on 2014-08-27. The cleared use is as an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at more than 36 completed weeks, in labour, with singleton pregnancies, used by healthcare professionals in a clinical setting. The indication names intrapartum use in a clinical setting; it does not name antepartum use or use at home.

Limitations. Clearance means FDA found the device substantially equivalent to earlier devices; it is not an approval and not a recommendation to use the device for any one woman. The sources disagree on the product code: FDA's clearance letter gives HGM (21 CFR 884.2740, class II), while the openFDA record gives OSP (21 CFR 884.2720). Both are shown and are not reconciled here; the decision records the letter's code. The 510(k) summary describes a comparison with the predicate monitor in 31 patients in labour; this record gives no accuracy numbers. 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: Novii wireless patch system (fetal heart rate from the abdomen)

Applies to Mixed recipients
  • Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).
  • Clinical setting, used by healthcare professionals
  • United States (FDA labelling)
  • Antepartum and intrapartum, from 34 weeks 0 days of gestation
  • Gestational age at least 34 weeks 0 days, measured at the time of measurement
  • 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
K231964
Product code
HGM
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Novii+ Wireless Patch System, as cleared under K231964
Indication
An antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at 34 weeks and 0/7 days and greater with singleton pregnancies, for use by healthcare professionals in a clinical setting.
Basis
FDA cleared the Novii+ Wireless Patch System (Datex Ohmeda) under 510(k) K231964 on 2023-12-08. The cleared use is as an antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at 34 weeks and 0/7 days and greater with singleton pregnancies, used by healthcare professionals in a clinical setting. The 510(k) summary names the Monica Novii Wireless Patch system (K140862) as its predicate device.

Limitations. Clearance means FDA found the device substantially equivalent to a predicate; it is not an approval. The indication names a clinical setting and healthcare professionals; it does not name use at home. The clinical study described in the summary enrolled 30 subjects between 34+0 and 36+6 weeks (see the performance claim). 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:novii-wireless-patch
Content hash
4f027543cb9d86a9f9f1cab866e239c3b3d104dac65bab82f39367887c400ccc