Bakri Postpartum Balloon

A silicone balloon on a catheter that is placed inside the uterus (womb) after birth and expanded with fluid so it presses on the uterine walls. In the United States the FDA cleared it, and a version with rapid-fill parts, in 2017 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market. Its cleared use is "temporary control or reduction of postpartum uterine bleeding when conservative management is warranted".

Product
In this atlas

Overview

Technical summary

Cook Incorporated. Special 510(k) K170622, decision Substantially Equivalent on 2017-03-31, product code OQY, regulation 21 CFR 884.4530, class II, for the Bakri Postpartum Balloon and the Bakri Postpartum Balloon with Rapid Instillation Components. The indication for each is to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The summary names the earlier Bakri Postpartum Balloon (K062438) as the predicate and describes a tamponade balloon catheter with a balloon of 500 mL at most; that earlier clearance was not read. The clearance covers that use only.

Product details

Type: Device
Model or formulation: Bakri Postpartum Balloon and Bakri Postpartum Balloon with Rapid Instillation Components, as named in openFDA 510(k) record K170622
Version: As cleared under K170622 on 2017-03-31

Intended-use sources

Background FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622

Locator
Whole source

How it applies
Source of the stated intended use

Retrieved
2026-10-15T13:49:18Z

Source effective date
2026-10-05

Source state
Current

Snapshot hash
24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33

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-k170622.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.
Background FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622

Locator
Whole source

How it applies
Source of the stated intended use

Retrieved
2026-10-15T13:53:06Z

Source effective date
Not reported

Source state
Current

Snapshot hash
ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b

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-k170622.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 Postpartum uterine bleeding when conservative management is warranted, US 510(k) clearance of the Bakri Postpartum Balloon (K170622)

Recipient: Maternal
Population: Women with postpartum uterine bleeding for whom conservative management is warranted. The cleared use is temporary control or reduction of that bleeding (510(k) Indications for Use), for both the Bakri Postpartum Balloon and the version with Rapid Instillation Components. It is not cleared for other uses.
Care setting: Not stated in the source
Geography: United States (FDA clearance)
Life stage: After birth, 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 uterine bleeding 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 Bakri Postpartum Balloon and the Bakri Postpartum Balloon with Rapid Instillation Components from applicant Cook Incorporated under Special 510(k) K170622, with the decision Substantially Equivalent dated 2017-03-31. The Indications for Use say each is "intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon) and the device class is II. The summary names the earlier Bakri Postpartum Balloon (K062438) as the predicate, describes it as a tamponade balloon catheter with a balloon of 500 mL at most, and says the Rapid Instillation version adds a dual check valve and tubing.
Applies to Maternal
- Women with postpartum uterine bleeding for whom conservative management is warranted. The cleared use is temporary control or reduction of that bleeding (510(k) Indications for Use), for both the Bakri Postpartum Balloon and the version with Rapid Instillation Components. It is not cleared for other uses.
- Not stated in the source
- United States (FDA clearance)
- After birth, 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. The earlier clearance K062438 is named only as the predicate; it was not read.

Last checked
2026-10-15

Next evidence check due
Not scheduled
Sources and citations (4)
1. Supports FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622
  
  Locator
  results[0].decision_date and results[0].decision_description
  
  How it applies
  openFDA 510(k) JSON, CC0.
  
  Retrieved
  2026-10-15T13:49:18Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33
  
  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-k170622.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 K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622
  
  Locator
  results[0].product_code and results[0].openfda.device_name
  
  How it applies
  openFDA 510(k) JSON, CC0.
  
  Retrieved
  2026-10-15T13:49:18Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33
  
  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-k170622.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 K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622
  
  Locator
  Indications for Use form
  
  How it applies
  510(k) summary PDF released by FDA; short quotation.
  
  Retrieved
  2026-10-15T13:53:06Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b
  
  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-k170622.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 K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (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/pdf17/K170622.pdf), read as default pdftotext text, which gives the cleared indication. · 510(k): K170622
  
  Locator
  Predicate Device
  
  How it applies
  510(k) summary PDF released by FDA; short quotation.
  
  Retrieved
  2026-10-15T13:53:06Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b
  
  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-k170622.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: Bakri Postpartum Balloon

Applies to Maternal

Women with postpartum uterine bleeding for whom conservative management is warranted. The cleared use is temporary control or reduction of that bleeding (510(k) Indications for Use), for both the Bakri Postpartum Balloon and the version with Rapid Instillation Components. It is not cleared for other uses.
Not stated in the source
United States (FDA clearance)
After birth, 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, 2017-03-31
Pathway: 510(k)
Submission: K170622
Product code: OQY
Device class: Class II
Jurisdictions: United States; note: United States
Product version: Bakri Postpartum Balloon and Bakri Postpartum Balloon with Rapid Instillation Components as cleared under K170622 (special 510(k))
Indication: Cleared intended use for each device, as the Indications for Use word it: "intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted".

Basis: FDA cleared the Bakri Postpartum Balloon and the Bakri Postpartum Balloon with Rapid Instillation Components from applicant Cook Incorporated under Special 510(k) K170622, with the decision Substantially Equivalent dated 2017-03-31. The Indications for Use say each is "intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon) and the device class is II. The summary names the earlier Bakri Postpartum Balloon (K062438) as the predicate, describes it as a tamponade balloon catheter with a balloon of 500 mL at most, and says the Rapid Instillation version adds a dual check valve and tubing.
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. The earlier clearance K062438 is named only as the predicate; it was not read.

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

Record details

Record id: maternal:bakri-postpartum-balloon
Content hash: a382949c445c194e786ca0952befab3095f8d20a98c3824a5c06c9f2e9332fd6