Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bmw Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964439 | NEEDLE-FREE VALVED CONNECTOR AND CAP | Bmw Medical, Inc. | 1997-07-16 | 252 | 0 |
| K963806 | CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) | Bmw Medical, Inc. | 1996-12-12 | 80 | 2 |
| K963215 | CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML) | Bmw Medical, Inc. | 1996-11-14 | 90 | 0 |
| K963097 | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) | Bmw Medical, Inc. | 1996-10-18 | 70 | 4 |
| K962300 | CLAMPLESS VALVED CATHETER | Bmw Medical, Inc. | 1996-09-05 | 84 | 5 |
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