Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OEW — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143024 | CAS-One Liver | Cascination AG | 2015-04-28 | 189 | 0 |
| K101979 | EXPLORER LIVER (PASSIVE TRACKING) | Pathfinder Therapeutics, Inc. | 2011-02-09 | 210 | 0 |
| K093494 | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Pathfinder Therapeutics, Inc. | 2010-03-30 | 140 | 0 |
| K071063 | LINASYS | Pathfinder Therapeutics, Inc. | 2007-12-20 | 248 | 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