Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Becton Dickinson — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

147 daysmedian FDA review time

266 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243062	BD Intelliport System; BD Intelliport Reader (516230); BD In	Becton Dickinson	2025-06-20	266	0
K161810	BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein	Becton Dickinson	2017-02-09	223	0
K161306	BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein	Becton Dickinson	2016-08-08	90	0
K113241	BD EMERALD SINGLE USE, HYPODERMIC SYRINGE	Becton Dickinson	2011-11-28	26	0
K041478	BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCO	Becton Dickinson	2004-10-28	147	2
K042061	0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SY	Becton Dickinson	2004-08-26	24	13

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