Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bd Biosciences — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
269 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations | Bd Biosciences | 2015-02-27 | 269 | 0 |
| K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | Bd Biosciences | 2009-07-31 | 116 | 3 |
| K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | Bd Biosciences | 2008-08-14 | 106 | 2 |
| K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 | Bd Biosciences | 2007-06-06 | 43 | 1 |
| K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBE | Bd Biosciences | 2007-06-06 | 43 | 0 |
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 3 | Bd Biosciences | 2006-09-14 | 52 | 3 |
| K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WIT | Bd Biosciences | 2006-06-06 | 113 | 0 |
| K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE | Bd Biosciences | 2004-09-17 | 144 | 1 |
| K000611 | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLU | Bd Biosciences | 2000-05-18 | 85 | 0 |
| K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE | Bd Biosciences | 2000-05-05 | 45 | 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