Bakri Balloon: What It Is, FDA Classification and WHO Guidance

General product and regulatory information only. This page is not medical advice and does not describe how any device is placed or used on a patient.

Short answer

A Bakri balloon is a brand of intrauterine (uterine) tamponade balloon made by Cook Incorporated. FDA classifies the device category as Class II under product code OQY, and the Bakri Essential Postpartum Balloon is cleared for “temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.” “Uterine tamponade balloon” is the generic term. Bakri is one brand among several cleared under the same code.

Definition and scope

FDA’s 510(k) record for the Bakri Essential Postpartum Balloon (K223098, decision dated October 28, 2022) gives the common name “Intrauterine tamponade balloon.” The device is described as a double lumen silicone balloon catheter with a stopcock. One lumen is for drainage and one is for balloon inflation. The record lists a 24 Fr silicone shaft, an overall length of 58 cm and a maximum inflation volume of 500 mL.

The same record states that the device is supplied sterile, is intended for one-time use, and is packaged five to a marketing carton in a peel-open pouch. FDA reviewed it in the Division of Reproductive, Gynecology and Urology Devices. The predicate was the earlier Bakri Postpartum Balloon (K170622).

FDA’s classification database lists product code OQY as “Intrauterine Tamponade Balloon,” Class 2, regulation number 21 CFR 884.4530 (“Obstetric-Gynecologic Specialized Manual Instrument”), with the definition “provides temporary control or reduction of postpartum uterine bleeding.” Section 884.4530 is a group regulation covering many instrument types, so the clearance letter, not the regulation text, is the document that ties a specific balloon to it.

How it is used in practice

FDA’s indication ties the device to postpartum uterine bleeding “when conservative management is warranted,” which makes it a temporary measure within a wider treatment pathway, not a stand-alone treatment. This page does not cover placement or use on a patient; that belongs to the manufacturer’s instructions for use and the treating team.

The World Health Organization published its recommendation on uterine balloon tamponade for postpartum haemorrhage (PPH) on 15 April 2021. The WHO page limits the recommendation to “those settings where standard PPH treatment protocols are available and implemented.” In the published account of the recommendation by members of the WHO guideline development group (Obstetrics & Gynecology, 2022), the setting conditions include:

• immediate recourse to surgery and access to blood products are possible if needed;
• a first-line PPH treatment protocol is available and routinely implemented;
• staff are trained and skilled in PPH management, including the device, and the woman’s condition can be monitored regularly.

The WHO recommendation is a guideline for health systems and clinicians. It is not a statement about any individual patient.

Devices cleared under the same product code

FDA’s open 510(k) data lists 11 clearances under OQY (checked 30 October 2026). Bakri accounts for two of them (K170622 and K223098), which is why the brand name and the category are easy to confuse.

510(k)	Device name on the record	Applicant	Decision date
K253642	Jada System (Jada-2002)	Organon, LLC	2026-05-15
K230849	ELLAVI UBT	Sinapi Biomedical (Pty), Ltd.	2023-11-13
K223098	Bakri Essential Postpartum Balloon	Cook Incorporated	2022-10-28
K212757	Jada System	Alydia Health	2021-09-30
K201199	Jada System	Alydia Health	2020-08-28
K191264	Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)	Ujenzi Charitable Trust	2019-10-30
K170622	Bakri Postpartum Balloon; Bakri Postpartum Balloon with Rapid Instillation Component	Cook Incorporated	2017-03-31
K153591	ebb Complete Tamponade System	Clinical Innovations, LLC	2016-01-14
K150573	ebb Complete Tamponade System	Clinical Innovations, LLC	2015-03-25
K101535	BT-CATH	Utah Medical Products, Inc.	2011-01-11
K091958	Belfort-Dildy Obstetric Tamponade System	Glenveigh Surgical, LLC	2010-04-30

The table lists regulatory records only. A 510(k) clearance means FDA found a device substantially equivalent to a predicate. FDA’s letter for K223098 adds that this finding is not a determination that the device complies with other requirements of the Act. Each device has its own instructions for use, and the table says nothing about how the devices compare in performance.

Where it matters for labs, clinics and supply decisions

For staff who maintain obstetric supply lists or review product records, the sources above support a short record-reading checklist:

1. Category versus brand. Does the record say “Bakri,” or is it another device under OQY? Equipment lists and protocols that name only the brand can miss other cleared devices, and the reverse.
2. Clearance. Is there a 510(k) number, and does the device name on it match the product on the shelf?
3. Stated use. Does the indication match the intended role? For K223098 it is temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
4. Single use and sterile supply. K223098 describes a sterile, one-time-use product. Packaging and carton quantity are on the record.
5. Setting readiness. WHO ties the recommendation to settings where PPH protocols, surgical back-up and blood products are in place. Stocking a device does not satisfy that condition.

Facility-level lists such as the birthing center supply checklist and the home-birth midwife practice supply checklist sit alongside, not in place of, the device’s own labelling. For how 510(k) files are structured, see the guide to the FDA eSTAR submission template for 510(k) and De Novo.

Common misunderstandings

• “Bakri” means every uterine balloon. It is a Cook brand. The generic category is the intrauterine tamponade balloon, and FDA lists other manufacturers’ devices under the same product code.
• It is the same as other tamponade balloons. Balloon tamponade devices exist in other specialties. The Sengstaken-Blakemore tube is a separate device, covered in its own guide.
• The balloon is a first-line measure. The FDA indication refers to “when conservative management is warranted,” and the WHO recommendation applies to bleeding that has not responded to first-line treatment.
• A Class II clearance settles suitability for a given facility. The WHO conditions concern the setting, not the product record.

FAQ

What is a Bakri balloon?

It is Cook Incorporated’s brand of intrauterine tamponade balloon, a sterile, single-use, double lumen silicone balloon catheter cleared by FDA to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Is a Bakri balloon the same as a uterine tamponade balloon?

The Bakri balloon is one example of a uterine tamponade balloon. FDA lists several manufacturers’ devices under the same “Intrauterine Tamponade Balloon” product code (OQY).

How does FDA classify it?

Class II, product code OQY, under 21 CFR 884.4530, and cleared through the 510(k) pathway. The most recent Bakri record is K223098 (October 28, 2022).

What does WHO say about uterine balloon tamponade?

WHO’s 15 April 2021 recommendation applies only where standard PPH treatment protocols are available and implemented. The setting conditions are listed above.

Sources

• FDA, 510(k) K223098, Bakri Essential Postpartum Balloon, clearance letter and summary, 28 October 2022: accessdata.fda.gov (checked 30 October 2026).
• FDA, product classification OQY and 510(k) records via openFDA: classification, 510(k) list (checked 30 October 2026).
• World Health Organization, WHO recommendation on uterine balloon tamponade for the treatment of postpartum haemorrhage (PPH), 15 April 2021 (checked 30 October 2026).
• Weeks AD et al., “World Health Organization Recommendation for Using Uterine Balloon Tamponade to Treat Postpartum Hemorrhage,” Obstetrics & Gynecology 2022;139(3):458-462, doi:10.1097/AOG.0000000000004674 (checked 30 October 2026).