Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson & Company — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Sy | Becton Dickinson & Company | 2017-04-12 | 63 | 0 |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/av | Becton Dickinson & Company | 2017-03-21 | 88 | 0 |
| K150059 | BD FlowSmart Set | Becton, Dickinson Company | 2015-04-28 | 105 | 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