Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QQV · 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) |
|---|---|---|---|---|---|
| K222563 | BD Kiestra IdentifA | Becton, Dickinson and Company | 2023-08-31 | 372 | 0 |
| K223245 | Colibrà | Copan Wasp Srl | 2023-03-20 | 151 | 0 |
| K193138 | Colibri System | Copan Wasp Srl | 2021-12-27 | 775 | 0 |
| K191964 | BD Kiestra IdentifA | Becton, Dickinson and Company | 2021-11-03 | 834 | 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