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Jada System (intrauterine vacuum device)

A device placed inside the uterus (womb) after birth that uses vacuum, instead of a filled balloon, to press on the uterine walls. In the United States, FDA cleared it in 2020, an updated version in 2021 and a version from a new applicant in 2026 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market. Its cleared use is "control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted".

  • Product
  • In this atlas

Overview

Technical summary

Alydia Health (K201199, K212757) and Organon, LLC (K253642). 510(k) K201199, decision Substantially Equivalent on 2020-08-28, traditional clearance, product code OQY, regulation 21 CFR 884.4530, class II; Special 510(k) K212757, 2021-09-30, for an updated version with modifications to manufacturability, packaging and user experience; and Traditional 510(k) K253642, 2026-05-15, for Jada System (Jada-2002), with K212757 as predicate. All three state the same indication, quoted on this page. The K201199 summary names an earlier balloon device, cleared under K170622, as the predicate and says the compressed intrauterine loop is inserted transvaginally. The clearances cover that use only. Whether further Jada clearances exist beyond the three read here was not checked.

Product details

Type
Device
Model or formulation
Jada System (Jada® System in the FDA documents), as named in openFDA 510(k) records K201199 and K212757
Version
Original version as cleared under K201199 on 2020-08-28, updated version as cleared under K212757 on 2021-09-30, and Jada-2002 as cleared under K253642 on 2026-05-15

Intended-use sources

  1. Background FDA 510(k) premarket notification K201199: Jada System (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  2. Background FDA 510(k) premarket notification K201199: Jada System (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  3. Background FDA 510(k) premarket notification K212757: Jada System (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  4. Background FDA 510(k) premarket notification K212757: Jada System (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  5. Background FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  6. Background FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

Claims and evidence

Context Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (Jada-2002), K253642

Recipient
Maternal
Population
The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.
Care setting
Not stated in the source
Geography
United States (FDA clearance)
Life stage
After birth, abnormal postpartum uterine bleeding
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted
Excluded
  • Any other use: the clearance covers only the stated indication

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared the Jada System (Jada-2002) from applicant Organon, LLC under Traditional 510(k) K253642, with the decision Substantially Equivalent dated 2026-05-15. The Indications for Use are the same as for the earlier Jada System clearances: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary names the Jada System cleared under K212757 as the predicate and says the subject and predicate have identical indications for use statements. The product code is OQY and the device class is II.

    Applies to Maternal
    • The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.
    • Not stated in the source
    • United States (FDA clearance)
    • After birth, abnormal postpartum uterine bleeding
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (5)

    1. Supports FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

      Locator
      results[0].decision_date and results[0].decision_description
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    2. Supports FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

      Locator
      results[0].product_code and results[0].openfda.device_name
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    3. Supports FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

      Locator
      Indications for Use form and section V
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    4. Supports FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

      Locator
      Predicate Device
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    5. Supports FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K253642

      Locator
      Section VI
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

Context Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (K201199)

Recipient
Maternal
Population
Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.
Care setting
Not stated in the source
Geography
United States (FDA clearance)
Life stage
After birth, abnormal postpartum uterine bleeding
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted
Excluded
  • Any other use: the clearance covers only the stated indication

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared the Jada System from applicant Alydia Health under 510(k) K201199, with the decision Substantially Equivalent dated 2020-08-28. The Indications for Use state that the device is "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon), the regulation is 21 CFR 884.4530 and the device class is II. The 510(k) summary names the Bakri Postpartum Balloon (K170622) as the predicate and says the Jada System uses vacuum to affect tamponade on the uterine walls, where the predicate uses the fluid pressure of an expanding balloon.

    Applies to Maternal
    • Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.
    • Not stated in the source
    • United States (FDA clearance)
    • After birth, abnormal postpartum uterine bleeding
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports FDA 510(k) premarket notification K201199: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

      Locator
      results[0].decision_date and results[0].decision_description
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    2. Supports FDA 510(k) premarket notification K201199: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

      Locator
      results[0].product_code and results[0].openfda.device_name
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    3. Supports FDA 510(k) premarket notification K201199: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

      Locator
      Indications for Use form and section V
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    4. Supports FDA 510(k) premarket notification K201199: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K201199

      Locator
      Section VI, technological differences
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

Context Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the updated Jada System (K212757)

Recipient
Maternal
Population
The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.
Care setting
Not stated in the source
Geography
United States (FDA clearance)
Life stage
After birth, abnormal postpartum uterine bleeding
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted
Excluded
  • Any other use: the clearance covers only the stated indication

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA cleared an updated Jada System from applicant Alydia Health under Special 510(k) K212757, with the decision Substantially Equivalent dated 2021-09-30. The Indications for Use are the same as for the earlier Jada System clearance: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary says the subject device is an updated version of the earlier Jada System with modifications to improve manufacturability, streamline packaging and improve user experience and aesthetics. The product code is OQY and the device class is II.

    Applies to Maternal
    • The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.
    • Not stated in the source
    • United States (FDA clearance)
    • After birth, abnormal postpartum uterine bleeding
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports FDA 510(k) premarket notification K212757: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

      Locator
      results[0].decision_date and results[0].decision_description
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    2. Supports FDA 510(k) premarket notification K212757: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

      Locator
      results[0].product_code and results[0].openfda.device_name
      How it applies
      openFDA 510(k) JSON, CC0.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    3. Supports FDA 510(k) premarket notification K212757: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

      Locator
      Section V, Indications for Use
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

    4. Supports FDA 510(k) premarket notification K212757: Jada System (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K212757

      Locator
      Section VI
      How it applies
      510(k) summary PDF released by FDA; short quotation.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

Authorization

Regulatory decision: Jada System (intrauterine vacuum device)

Applies to Maternal
  • Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.
  • Not stated in the source
  • United States (FDA clearance)
  • After birth, abnormal postpartum uterine bleeding
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K201199
Product code
OQY
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Jada System as cleared under K201199 (traditional 510(k))
Indication
Cleared intended use, as the Indications for Use word it: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted".
Basis
FDA cleared the Jada System from applicant Alydia Health under 510(k) K201199, with the decision Substantially Equivalent dated 2020-08-28. The Indications for Use state that the device is "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon), the regulation is 21 CFR 884.4530 and the device class is II. The 510(k) summary names the Bakri Postpartum Balloon (K170622) as the predicate and says the Jada System uses vacuum to affect tamponade on the uterine walls, where the predicate uses the fluid pressure of an expanding balloon.

Limitations. Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.

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

Regulatory decision: Jada System (intrauterine vacuum device)

Applies to Maternal
  • The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.
  • Not stated in the source
  • United States (FDA clearance)
  • After birth, abnormal postpartum uterine bleeding
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K212757
Product code
OQY
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Updated Jada System as cleared under K212757 (special 510(k))
Indication
Cleared intended use, identical to the earlier Jada System: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted".
Basis
FDA cleared an updated Jada System from applicant Alydia Health under Special 510(k) K212757, with the decision Substantially Equivalent dated 2021-09-30. The Indications for Use are the same as for the earlier Jada System clearance: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary says the subject device is an updated version of the earlier Jada System with modifications to improve manufacturability, streamline packaging and improve user experience and aesthetics. The product code is OQY and the device class is II.

Limitations. Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.

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

Regulatory decision: Jada System (intrauterine vacuum device)

Applies to Maternal
  • The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.
  • Not stated in the source
  • United States (FDA clearance)
  • After birth, abnormal postpartum uterine bleeding
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K253642
Product code
OQY
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Jada System (Jada-2002) as cleared under K253642 (traditional 510(k))
Indication
Cleared intended use, identical to the earlier Jada System: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted".
Basis
FDA cleared the Jada System (Jada-2002) from applicant Organon, LLC under Traditional 510(k) K253642, with the decision Substantially Equivalent dated 2026-05-15. The Indications for Use are the same as for the earlier Jada System clearances: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary names the Jada System cleared under K212757 as the predicate and says the subject and predicate have identical indications for use statements. The product code is OQY and the device class is II.

Limitations. Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.

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

Record details

Record id
maternal:jada-system
Content hash
bf924e7adb5c89eb128d8c76568143f33a8f2593df58f6587c1edcbfce322670