Medical device manufacturer

Bd Becton Dickinson Vacutainer Systems Preanalytic

Bd Becton Dickinson Vacutainer Systems Preanalytic holds 632 FDA 510(k) clearances across 236 product codes. Median elapsed review time is 47 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 632
Product codes: 236
Median review: 47 days
Recall records: 0

How does FDA spell Bd Becton Dickinson Vacutainer Systems Preanalytic?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Bd Becton Dickinson Vacutainer Systems Preanalytic file in?

236 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
JTN	Susceptibility Test Discs, Antimicrobial	43	42 days	25 April 2000
JWY	Manual Antimicrobial Susceptibility Test Systems	32	38 days	7 March 1990
FMF	Syringe, Piston	23	86 days	15 July 1998
FMI	Needle, Hypodermic, Single Lumen	20	93 days	1 February 2001
JSJ	Culture Media, Selective And Non-Differential	16	17 days	21 May 1987
GKZ	Counter, Differential Cell	15	86 days	23 September 1999
FRN	Pump, Infusion	14	63 days	8 May 1992
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	13	80 days	23 September 1999
LYZ	Vinyl Patient Examination Glove	13	108 days	26 January 1995
GKL	Counter, Cell, Automated (Particle Counter)	11	67 days	22 September 1992
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	10	101 days	21 March 2001
JSH	Culture Media, Non-Selective And Differential	10	15 days	2 June 1987
JHI	Visual, Pregnancy Hcg, Prescription Use	9	51 days	9 August 1990
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	9	41 days	20 June 1991
KGO	Surgeon'S Gloves	9	137 days	16 May 1994
CEC	Radioimmunoassay, Free Thyroxine	8	71 days	20 April 1993
KZJ	Device, Gas Generating	8	20 days	6 August 1987
CAZ	Anesthesia Conduction Kit	7	97 days	20 May 1996
GTZ	Antisera, All Groups, Streptococcus Spp.	7	71 days	20 October 1995
JSI	Culture Media, Selective And Differential	7	24 days	31 October 1986
MDB	System, Blood Culturing	7	79 days	1 May 1998
CDX	Radioimmunoassay, Total Thyroxine	6	31 days	17 January 1991
JTA	Monitor, Microbial Growth	6	14 days	11 March 1991
JTO	Discs, Strips And Reagents, Microorganism Differentiation	6	19 days	23 August 1991
JCF	Lymphocyte Separation Medium	5	80 days	15 December 1992

Showing the 25 they file in most, of 236.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Bd Becton Dickinson Vacutainer Systems Preanalytic had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Bd Becton Dickinson Vacutainer Systems Preanalytic cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K003062	BACTEC MGIT 960 SIR KITS	MJA	6 June 2001	247
K003553	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE	FOZ	21 March 2001	124
K003461	BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE	FMI	1 February 2001	86
K002938	B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16	FMI	29 November 2000	69
K001364	BD DIRECTIGEN FLU A+B	PSZ	28 June 2000	58
K000762	MOXIFLOXACIN, 5 UG, BBL SENSI-DISC	JTN	25 April 2000	48
K000829	GATIFLOXACIN, 5 UG, BBL SENSI-DISC	JTN	13 April 2000	30
K993186	SYNERCID, 15 UG, BBL SENSI-DISC	JTN	3 November 1999	42
K992734	BECTON DICKINSON SYRINGE	MEG	1 October 1999	49
K992849	QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM	GKZ	23 September 1999	30

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.