Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Colmed, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
52 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. | 1981-06-16 | 46 | 0 |
| K810636 | VARIODRAIN | Colmed, Ltd. | 1981-05-01 | 52 | 0 |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | 1981-02-10 | 25 | 0 |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. | 1980-05-28 | 8 | 0 |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | Colmed, Ltd. | 1980-05-20 | 22 | 0 |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | Colmed, Ltd. | 1980-05-14 | 37 | 0 |
| K792241 | PELIMIT | Colmed, Ltd. | 1979-11-30 | 23 | 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