OQY · Class II · 21 CFR 884.4530

FDA Product Code OQY: Intrauterine Tamponade Balloon

Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding

Leading manufacturers include Cook Incorporated, Alydia Health and Ujenzi Charitable Trust.

11
Total
11
Cleared
123d
Avg days
2010
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 177d recently vs 118d historically

FDA 510(k) Cleared Intrauterine Tamponade Balloon Devices (Product Code OQY)

11 devices
1–11 of 11
Cleared May 15, 2026
Jada System (Jada-2002)
K253642
Organon, LLC
Obstetrics & Gynecology · 177d
Cleared Nov 13, 2023
ELLAVI UBT
K230849
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology · 230d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098
Cook Incorporated
Obstetrics & Gynecology · 28d
Cleared Sep 30, 2021
Jada System
K212757
Alydia Health
Obstetrics & Gynecology · 30d
Cleared Aug 28, 2020
Jada System
K201199
Alydia Health
Obstetrics & Gynecology · 116d
Cleared Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264
Ujenzi Charitable Trust
Obstetrics & Gynecology · 173d
Cleared Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
K170622
Cook Incorporated
Obstetrics & Gynecology · 30d

About Product Code OQY - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code OQY since 2010, with 11 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - OQY Product Code

Recent submissions under OQY have taken an average of 177 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.

OQY devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →