Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OYE — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
249 daysmedian FDA review time
437 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023-11-22 | 86 | 1 |
| K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3- | Becton, Dickinson and Company | 2020-09-28 | 89 | 5 |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optic | Becton, Dickinson and Company | 2017-07-03 | 91 | 8 |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cy | Beckman Coulter | 2017-06-23 | 249 | 0 |
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA- | Beckman Coulter, Inc. | 2015-04-10 | 268 | 3 |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations | Bd Biosciences | 2015-02-27 | 269 | 0 |
| K130373 | NAVIOS FLOW CYTOMETER SYSTEM | Beckman Coulter, Inc. | 2013-09-18 | 216 | 0 |
| K121445 | TETRACHROME REAGENTS AND TETRACXP SYSTEM | Beckman Coulter, Inc. | 2013-07-26 | 437 | 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