Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precifit Medical, Ltd. — 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) |
|---|---|---|---|---|---|
| K173189 | Lumfuse TP | Precifit Medical, Ltd. | 2018-06-08 | 249 | 0 |
| K172568 | Cervage | Precifit Medical, Ltd. | 2018-05-04 | 252 | 0 |
| K171630 | LumFuse-TP | Precifit Medical, Ltd. | 2017-07-25 | 53 | 0 |
| K163327 | Precifit Medical Kirschner Wires | Precifit Medical, Ltd. | 2017-05-08 | 161 | 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