Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beckman Coulter — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
269 daysmedian FDA review time
326 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232904 | Access Ostase | Beckman Coulter | 2024-04-15 | 210 | 0 |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020-04-16 | 156 | 1 |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | 2019-09-06 | 326 | 0 |
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, | Beckman Coulter | 2019-03-21 | 90 | 0 |
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis In | Beckman Coulter | 2019-03-18 | 273 | 0 |
| K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019-03-01 | 270 | 0 |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, Clea | Beckman Coulter | 2017-06-29 | 269 | 0 |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cy | Beckman Coulter | 2017-06-23 | 249 | 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