Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GAF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
23 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | LeMaitre Vascular, Inc. | 2003-01-30 | 90 | 0 |
| K935357 | SNAP RECIPROCATING SAW | Surgiquip, Inc. | 1994-01-28 | 85 | 0 |
| K890374 | ABDOMINAL SPATULA | Kinetic Medical Products | 1989-02-03 | 11 | 0 |
| K882793 | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE | Pmt Corp. | 1988-07-18 | 12 | 0 |
| K822108 | CEMENT-PICK | Bio-Blitz, Inc. | 1982-08-11 | 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