OQY
11 FDA 510(k) clearances · Product code
116 daysmedian time to decision
230 days90th percentile
11clearances measured
FDA profile
- Official device name
- Intrauterine Tamponade Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- provides temporary control or reduction of postpartum uterine bleeding
- Adverse events (MAUDE)
- 2021: 113 · 2022: 274 · 2023: 228 · 2024: 215 · 2025: 180 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Jada System (Jada-2002) (K253642) | Organon, LLC | 2026-05-15 |
| ELLAVI UBT (K230849) | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 |
| Bakri Essential Postpartum Balloon (K223098) | Cook Incorporated | 2022-10-28 |
| Jada System (K212757) | Alydia Health | 2021-09-30 |
| Jada System (K201199) | Alydia Health | 2020-08-28 |
| Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (K191264) | Ujenzi Charitable Trust | 2019-10-30 |
| Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622) | Cook Incorporated | 2017-03-31 |
| ebb Complete Tamponade System (K153591) | Clinical Innovations, LLC | 2016-01-14 |
| ebb Complete Tamponade System (K150573) | Clinical Innovations, LLC | 2015-03-25 |
| BT-CATH (K101535) | Utah Medical Products, Inc. | 2011-01-11 |
| BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (K091958) | Glenveigh Surgical, LLC | 2010-04-30 |
Track OQY automatically
Every clearance here is in the API, with alerts when new ones post.