Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Weck · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030311 | HEM-O-LOK XL CLIP | Weck | 2003-02-26 | 27 | 1 |
| K021808 | WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER | Weck | 2002-08-14 | 72 | 6 |
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