Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FKA · 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) |
|---|---|---|---|---|---|
| K022620 | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRI | Spire Biomedical, Inc. | 2002-10-11 | 65 | 0 |
| K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR | Vas-Cath, Inc. | 1993-07-01 | 651 | 0 |
| K910502 | VESSEL DILATORS | Akcess Medical Products, Inc. | 1991-04-29 | 83 | 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