Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ventrex, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
226 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061044 | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | 2006-07-12 | 89 | 0 |
| K013477 | TOCO LITE, MODEL TD-01 | Ventrex, Inc. | 2002-01-17 | 90 | 0 |
| K964821 | COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 | Ventrex, Inc. | 1997-07-16 | 226 | 0 |
| K925044 | VENTREX ALLERGEN DISC | Ventrex, Inc. | 1993-05-14 | 221 | 0 |
| K924119 | VENTREX ALLERGEN DISC | Ventrex, Inc. | 1992-11-30 | 108 | 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