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

Becton, Dickinson & CO — Predicate Candidate Screening

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

52 daysmedian FDA review time

155 days90th percentile

190clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160164	BD Veritor System for Rapid Detection of Flu A + B Labratory	Becton, Dickinson & CO	2016-02-25	29	0
K160161	BD Veritor System for Rapid Detection of Flu A + B CLIA waiv	Becton, Dickinson & CO	2016-02-24	28	0
K141474	BECTON DICKINSON INTELLIPORT SYSTEM	Becton, Dickinson & CO	2014-12-18	198	1
K140448	BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2014-05-20	88	0
K140446	BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2014-05-20	88	0
K140591	BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR	Becton, Dickinson & CO	2014-05-14	68	1
K133140	BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV	Becton, Dickinson & CO	2013-11-15	29	0
K133138	BD Veritor™ System Flu A+B Assay	Becton, Dickinson & CO	2013-11-13	27	0
K130268	BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2013-08-23	200	0
K131301	BD FACS SAMPLE PREP ASSISTANT III	Becton, Dickinson & CO	2013-08-02	87	0
K131358	BD PEN NEEDLE	Becton, Dickinson & CO	2013-07-16	67	0
K131331	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-3	Becton, Dickinson & CO	2013-07-10	62	4
K123404	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-3	Becton, Dickinson & CO	2013-06-27	234	0
K123903	BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)	Becton, Dickinson & CO	2013-05-13	145	0
K121655	BD ALCOHOL SWAB	Becton, Dickinson & CO	2013-03-20	288	0
K121050	0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRING	Becton, Dickinson & CO	2013-02-07	307	1
K123300	BD PEN NEEDLE	Becton, Dickinson & CO	2013-01-18	87	0
K123213	BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE	Becton, Dickinson & CO	2013-01-09	86	1
K111860	BD MAX GBS ASSAY, BD MAX INSTRUMENT	Becton, Dickinson & CO	2012-02-16	231	7
K110443	BD INSYTE AUTOGUARD BC	Becton, Dickinson & CO	2011-07-19	153	0
K103798	BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DN	Becton, Dickinson & CO	2011-03-18	81	0
K102064	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	Becton, Dickinson & CO	2011-03-07	227	0
K092767	BBL CHROMAGAR MRSA II	Becton, Dickinson & CO	2010-08-20	345	0
K101514	BD DIRECTIGEN EZ RSV	Becton, Dickinson & CO	2010-07-09	37	0
K101502	BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL	Becton, Dickinson & CO	2010-06-29	28	0
K101529	BD DIRECTIGEN EZ FLU A+B ASSAY	Becton, Dickinson & CO	2010-06-14	12	0
K100209	BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY	Becton, Dickinson & CO	2010-02-19	25	0
K093972	BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 36	Becton, Dickinson & CO	2010-01-21	28	1
K091724	BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY	Becton, Dickinson & CO	2009-11-13	155	0
K091730	BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2009-11-13	155	1
K091377	BD FLU+ SYRINGE	Becton, Dickinson & CO	2009-07-02	52	0
K091670	BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER	Becton, Dickinson & CO	2009-07-01	22	0
K090680	HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK F	Becton, Dickinson & CO	2009-06-10	86	0
K090971	BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2009-06-05	60	1
K090824	BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2009-06-02	68	0
K090827	BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2009-05-27	62	1
K082852	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP)	Becton, Dickinson & CO	2009-01-29	122	0
K083572	BD BACTEC Plus Aerobic/F Culture Vials	Becton, Dickinson & CO	2008-12-24	21	0
K081825	BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY	Becton, Dickinson & CO	2008-12-11	167	1
K081824	BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY	Becton, Dickinson & CO	2008-12-11	167	0
K082913	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.	Becton, Dickinson & CO	2008-12-05	66	0
K082538	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE M	Becton, Dickinson & CO	2008-11-20	79	0
K082271	FLUCONAZOLE 25UG BBL SENSI-DISC	Becton, Dickinson & CO	2008-10-06	56	0
K082272	VORICONAZOLE 1UG BBL SENSI-DISC	Becton, Dickinson & CO	2008-10-02	52	0
K081446	BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237	Becton, Dickinson & CO	2008-07-17	56	0
K080998	DORIPENEM 10UG BBL SENSI-DISC	Becton, Dickinson & CO	2008-05-12	35	1
K073589	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-	Becton, Dickinson & CO	2008-03-05	76	0
K073433	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -	Becton, Dickinson & CO	2008-01-14	39	0
K070691	BBL CHROMAGAR 0157	Becton, Dickinson & CO	2007-11-20	252	0
K070809	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-	Becton, Dickinson & CO	2007-09-24	182	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