Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionomy, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851101 | BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET | Bionomy, Inc. | 1985-04-12 | 24 | 0 |
| K844094 | PRUITT IRRIGATION AND OCCLUSION CATHETER | Bionomy, Inc. | 1984-11-29 | 42 | 0 |
| K832023 | EMBOLECTOMY CATHETER | Bionomy, Inc. | 1983-08-31 | 79 | 0 |
| K812111 | PRUITT ARTERIAL OCCLUSION CHOLANG. CATH | Bionomy, Inc. | 1981-11-16 | 112 | 0 |
| K811276 | OCCLUSION CATHETER | Bionomy, Inc. | 1981-06-30 | 53 | 1 |
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