Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PER · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131301 | BD FACS SAMPLE PREP ASSISTANT III | Becton, Dickinson & CO | 2013-08-02 | 87 | 0 |
| K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | Beckman Coulter, Inc. | 2013-07-15 | 164 | 0 |
| K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINIC | Becton, Dickinson & CO | 2005-02-22 | 26 | 2 |
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