# Bakri Postpartum Balloon Product · id `maternal:bakri-postpartum-balloon` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Childbirth; Postpartum Browse, care area: Recovery after birth ## In plain language 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". ## 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. ## Claims, with the population each applies to ## 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) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record) (Regulator, 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.) Locator: results\[0\].decision\_date and results\[0\].decision\_description. Retrieved 2026-10-15T13:49:18Z. Source state: Current. Snapshot hash: 24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record) (Regulator, 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.) Locator: results\[0\].product\_code and results\[0\].openfda.device\_name. Retrieved 2026-10-15T13:49:18Z. Source state: Current. Snapshot hash: 24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record) (Regulator, 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.) Locator: Indications for Use form. Retrieved 2026-10-15T13:53:06Z. Source state: Current. Snapshot hash: ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b. How it applies: 510(k) summary PDF released by FDA; short quotation. 4. Supports: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record) (Regulator, 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.) Locator: Predicate Device. Retrieved 2026-10-15T13:53:06Z. Source state: Current. Snapshot hash: ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b. How it applies: 510(k) summary PDF released by FDA; short quotation. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k170622` - Product: Bakri Postpartum Balloon (`maternal:bakri-postpartum-balloon`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2017-03-31 - Product version: Bakri Postpartum Balloon and Bakri Postpartum Balloon with Rapid Instillation Components as cleared under K170622 (special 510(k)) - Pathway: 510(k) - Submission: K170622 - Product code: OQY - Device class: II - 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". - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-k170622-indication` ## Connected pages - Balloon tamponade: Uterine balloon or vacuum tamponade for postpartum haemorrhage (`maternal:uterine-balloon-tamponade`) - Filed under this front: Procedures and birth care (`maternal:front-procedures-and-birth-care`) ## Provenance Content hash: a382949c445c194e786ca0952befab3095f8d20a98c3824a5c06c9f2e9332fd6 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15