FDA Product Code OQY: Intrauterine Tamponade Balloon
Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
Leading manufacturers include Alydia Health, Cook Incorporated and Sinapi Biomedical (Pty) , Ltd..
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
Cleared
May 15, 2026
Jada System (Jada-2002)
Organon, LLC
Obstetrics & Gynecology
177d
Cleared
Nov 13, 2023
ELLAVI UBT
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology
230d
Cleared
Oct 28, 2022
Bakri Essential Postpartum Balloon
Cook Incorporated
Obstetrics & Gynecology
28d
Cleared
Sep 30, 2021
Jada System
Alydia Health
Obstetrics & Gynecology
30d
Cleared
Aug 28, 2020
Jada System
Alydia Health
Obstetrics & Gynecology
116d
Cleared
Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Ujenzi Charitable Trust
Obstetrics & Gynecology
173d
Cleared
Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
Cook Incorporated
Obstetrics & Gynecology
30d
Cleared
Jan 11, 2011
BT-CATH
Utah Medical Products, Inc.
Obstetrics & Gynecology
222d
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 →