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Bd Becton Dickinson Vacutainer Systems Preanalytic — Predicate Candidate Screening

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

47 daysmedian FDA review time

150 days90th percentile

632clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K003062	BACTEC MGIT 960 SIR KITS	Bd Becton Dickinson Vacutainer Systems Preanalytic	2001-06-06	247	0
K003553	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRI	Bd Becton Dickinson Vacutainer Systems Preanalytic	2001-03-21	124	0
K003461	BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	2001-02-01	86	0
K002938	B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000-11-29	69	0
K001364	BD DIRECTIGEN FLU A+B	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000-06-28	58	0
K000762	MOXIFLOXACIN, 5 UG, BBL SENSI-DISC	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000-04-25	48	1
K000829	GATIFLOXACIN, 5 UG, BBL SENSI-DISC	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000-04-13	30	0
K993186	SYNERCID, 15 UG, BBL SENSI-DISC	Bd Becton Dickinson Vacutainer Systems Preanalytic	1999-11-03	42	0
K992734	BECTON DICKINSON SYRINGE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1999-10-01	49	6
K991551	VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1999-09-23	143	0
K992849	QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1999-09-23	30	0
K984059	ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1999-04-09	147	0
K980185	COLORPAC TOXIN A	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-07-17	178	0
K972728	STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-07-15	359	0
K980580	BECTON DICKINSON SYRINGES	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-06-25	128	0
K981797	B-D PEN ULTRA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-06-12	22	0
K980987	BECTON DICKINSON SYRINGE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-06-11	86	13
K974363	BECTON DICKINSON BLUNT PLASTIC CANNULA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-06-03	196	2
K974678	B-D AUTO-INJECTOR	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-05-29	165	0
K974883	BACTEC MGIT 960 SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-05-01	122	2
K980755	B-D E ML PEN	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-04-02	36	0
K980414	VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTI	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-03-03	28	1
K974006	BECTON DICKINSON TWINPAK	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998-01-22	93	0
K972404	VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997-07-22	26	0
K964654	BECTON DICKINSON BLUNT PLASTIC CANNULA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997-04-02	133	0
K970737	B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997-03-28	28	0
K965202	VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997-02-10	46	0
K961968	BBLCRYSTAL GRAM-POSITIVE ID SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997-02-04	260	0
K952721	RUBASCAN CARD TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-12-20	554	0
K952791	DIRECTIGEN MENINGITIS COMBO TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-05-30	346	0
K954953	B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-05-20	203	0
K961188	CEFEPIME, 30 MCG, SENSI-DISC	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-04-05	10	1
K955235	B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-02-12	90	1
K953790	BD PERISAFE EPIDURAL ANESTHESIA TRAY	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-11-30	108	0
K954064	BECTON DICKINSON SYRINGSE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-11-21	83	0
K953467	B-D SPINAL ANESTHESIA TRAY SPINAL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-10-27	95	0
K951919	B-D PEN ULTRA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-10-24	183	0
K951542	DIRECTIGEN 1-2-3 GROUP A STREP TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-10-20	200	0
K951254	SAFETYGLIDE NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-10-07	200	0
K944931	BECTON DICKINSON BLUNT STEEL CANNULA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-08-29	327	1
K950995	SENSICARE SYNTHETIC, SURGICAL GLOVE LINER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-06-28	117	0
K945427	B-D DIGITAL THERMOMETER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-06-15	223	0
K950466	B-D ULTRA-FINE II PEN NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-05-11	97	0
K950432	VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-05-05	92	0
K945497	B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-02-13	97	0
K945813	BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-02-07	71	0
K945458	VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-02-06	91	0
K944183	TRU-TOUCH MEDICAL GLOVES	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-01-26	153	0
K945952	VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-01-18	43	2
K944757	PISTON SYRINGES	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995-01-11	106	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