Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Voss Medical Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
374 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932186 | BYPASS LEG POSITIONER | Voss Medical Products | 1993-06-01 | 27 | 0 |
| K932187 | PRONE POSITIONER | Voss Medical Products | 1993-06-01 | 27 | 0 |
| K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA | Voss Medical Products | 1990-05-17 | 195 | 0 |
| K885161 | VOSS VEIN CLAMP | Voss Medical Products | 1989-12-22 | 374 | 0 |
| K895369 | VOSS GRAFT MARKER | Voss Medical Products | 1989-09-27 | 29 | 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