Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Weck Closure Systems — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
90 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011660 | WECK CARDIAC PACING WIRES | Weck Closure Systems | 2001-08-21 | 84 | 0 |
| K003337 | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM | Weck Closure Systems | 2000-12-21 | 57 | 2 |
| K993157 | HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POL | Weck Closure Systems | 1999-12-17 | 87 | 1 |
| K982944 | HEM-O-LOCK, MODEL 523935 | Weck Closure Systems | 1998-11-19 | 90 | 0 |
| K982941 | HEM-O-LOK MODEL NUMBERS 523900, 523970 | Weck Closure Systems | 1998-11-19 | 90 | 1 |
| K982313 | HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS | Weck Closure Systems | 1998-08-10 | 40 | 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