Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OQY — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
230 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253642 | Jada System (Jada-2002) | Organon, LLC | 2026-05-15 | 177 | 0 |
| K230849 | ELLAVI UBT | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 | 230 | 0 |
| K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | 2022-10-28 | 28 | 0 |
| K212757 | Jada System | Alydia Health | 2021-09-30 | 30 | 0 |
| K201199 | Jada System | Alydia Health | 2020-08-28 | 116 | 0 |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) | Ujenzi Charitable Trust | 2019-10-30 | 173 | 0 |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapi | Cook Incorporated | 2017-03-31 | 30 | 0 |
| K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016-01-14 | 29 | 0 |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015-03-25 | 19 | 1 |
| K101535 | BT-CATH | Utah Medical Products, Inc. | 2011-01-11 | 222 | 0 |
| K091958 | BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM | Glenveigh Surgical, LLC | 2010-04-30 | 303 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda