Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton, Dickinson and Company (BD) — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
137 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253996 | BD Surgiphorâ„¢ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026-02-25 | 75 | 0 |
| K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | Becton, Dickinson and Company (BD) | 2011-10-18 | 42 | 1 |
| K111366 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | Becton, Dickinson and Company (BD) | 2011-09-30 | 137 | 0 |
| K110105 | BD PEN NEEDLE | Becton, Dickinson and Company (BD) | 2011-04-28 | 105 | 0 |
| K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, M | Becton, Dickinson and Company (BD) | 2009-08-25 | 113 | 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