Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PWD · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, | Beckman Coulter | 2019-03-21 | 90 | 0 |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, Clea | Beckman Coulter | 2017-06-29 | 269 | 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