Cleared Special

K223098 - Bakri Essential Postpartum Balloon

K223098 is an FDA 510(k) clearance for Bakri Essential Postpartum Balloon, manufactured by Cook Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code OQY cleared through the Special 510(k) pathway after a 28-day FDA review.

K223098 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
28d
Days
Class 2
Risk

K223098 is an FDA 510(k) clearance for the Bakri Essential Postpartum Balloon. Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 28, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K223098

510(k) Number K223098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date October 28, 2022
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

OQY Device Classification - Class 2, Special Controls

Product Code OQY Intrauterine Tamponade Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - OQY Intrauterine Tamponade Balloon

All 10
Devices cleared under the same product code (OQY) and FDA review panel - the closest regulatory comparables to K223098.
Jada System (Jada-2002)
K253642 · Organon, LLC · May 2026
ELLAVI UBT
K230849 · Sinapi Biomedical (Pty) , Ltd. · Nov 2023
Jada System
K212757 · Alydia Health · Sep 2021
Jada System
K201199 · Alydia Health · Aug 2020
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · Ujenzi Charitable Trust · Oct 2019
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
K170622 · Cook Incorporated · Mar 2017
K223098 · Bakri Essential Postpartum Balloon
Download PDF FDA Summary Cook Incorporated