Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venetec, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943038 | STATLOCK-IPIDURAL | Venetec, Inc. | 1995-04-10 | 287 | 0 |
| K942931 | STATLOCK SECUREMENT DEVICES | Venetec, Inc. | 1995-03-28 | 279 | 0 |
| K943147 | STATLOCK CV | Venetec, Inc. | 1994-09-29 | 91 | 0 |
| K902109 | STATLOCK IV CONNECTOR AND ANCHOR SET | Venetec, Inc. | 1990-10-19 | 163 | 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