Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKW · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893438 | T SERIES VESSEL TIPS | Akcess Medical Products, Inc. | 1989-06-08 | 36 | 0 |
| K810257 | VESSEL TIPS, SIZES 13-18 | Quinton, Inc. | 1981-03-13 | 42 | 0 |
| K791645 | VICKERS MEDICAL MODEL 112 TREONIC DC2 | Vickers America Medical Corp. | 1979-10-02 | 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