Product Code: MDB FDA class 1 21 CFR 866.2560

System, Blood Culturing

Microbiology

The blood culturing system is a microbiology laboratory device used to incubate and monitor blood samples for the presence and growth of bacteria or fungi, supporting the diagnosis of bacteremia and septicemia. It is classified as FDA Class I under 21 CFR 866.2560 within the Microbiology specialty, subject only to general controls. The product code is MDB and the device is not GMP-exempt. It is not implanted and does not sustain life.

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510(k)s

FEI Numbers

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Basic Information

Product Code: MDB
Device Class: FDA class 1
Regulation Number: 866.2560
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 68 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260213	BD BACTEC FXI Culture System	May 28, 2026	Substantially Equivalent	BD Diagnostic Systems
K222591	BD BACTEC Plus Aerobic/F Culture Vials	Mar 24, 2023	Substantially Equivalent	Becton, Dickinson and Company
K222559	BD BACTEC Myco/F Lytic Culture Vials	Mar 24, 2023	Substantially Equivalent	Becton, Dickinson and Company
K190405	BACT/ALERT MP Reagent System	May 15, 2019	Substantially Equivalent	bioMerieux, Inc.
K183166	BacT/ALERT FA Plus; BacT/ALERT PF Plus	Feb 11, 2019	Substantially Equivalent	bioMerieux, Inc.
K173873	BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial	Mar 16, 2018	Substantially Equivalent	Becton, Dickinson and Company
K161816	BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO	Mar 28, 2017	Substantially Equivalent	bioMerieux, Inc.
K161810	BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial	Feb 09, 2017	Substantially Equivalent	Becton Dickinson
K161306	BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial	Aug 08, 2016	Substantially Equivalent	Becton Dickinson
K151866	BD BACTEC Peds Plus/F Culture Vials (plastic)	Feb 25, 2016	Substantially Equivalent	Becton, Dickinson and Company
K141810	BD BACTEC PLUS ANAEROBIC/F (PLASTIC)	Dec 10, 2014	Substantially Equivalent	Becton, Dickinson and Company
K123903	BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)	May 13, 2013	Substantially Equivalent	Becton, Dickinson & CO
K121455	BACT/ALERT FN PLUS CULTURE BOTTLE	Jan 25, 2013	Substantially Equivalent	bioMerieux, Inc.
K121446	BACT/ALERT PF PLUS CULTURE BOTTLE	Jan 25, 2013	Substantially Equivalent	bioMerieux, Inc.
K121461	BACT/ALERT FA PLUS CULTURE BOTTLE	Jan 22, 2013	Substantially Equivalent	bioMerieux, Inc.
K120994	BD BACTEC Plus PRIME Aerobic/F Culture Vials	Aug 07, 2012	Substantially Equivalent	Becton, Dickinson and Company
K113558	BD BACTEC Plus Aerobic/F Culture Vials (plastic)	Mar 16, 2012	Substantially Equivalent	Becton, Dickinson and Company
K083572	BD BACTEC Plus Aerobic/F Culture Vials	Dec 24, 2008	Substantially Equivalent	Becton, Dickinson & CO
K032306	VERSATREK	Aug 22, 2003	Substantially Equivalent	Trek Diagnostic Systems, Inc.
K031737	BACT/ALERT MP CULTURE BOTTLES (PLASTIC)	Jul 14, 2003	Substantially Equivalent	bioMerieux, Inc.
K021123	BACT/ALERT SN CULTURE BOTTLE	Apr 26, 2002	Substantially Equivalent	bioMerieux, Inc.
K020931	BACT/ALERT SA CULTURE BOTTLE	Apr 18, 2002	Substantially Equivalent	bioMerieux, Inc.
K020923	BACT/ALERT PF CULTURE BOTTLE	Apr 18, 2002	Substantially Equivalent	bioMerieux, Inc.
K020815	BACT/ALERT FN CULTURE BOTTLE	Apr 18, 2002	Substantially Equivalent	bioMerieux, Inc.
K020813	BACT/ALERT FA CULTURE BOTTLE	Apr 17, 2002	Substantially Equivalent	bioMerieux, Inc.
K000378	BACT/ALERT MB CULTURE BOTTLE	Mar 02, 2000	Substantially Equivalent	Organon Teknika Corp.
K994343	BACT/ALERT SV	Feb 10, 2000	Substantially Equivalent	Organon Teknika Corp.
K993423	BACT/ALERT SA	Dec 15, 1999	Substantially Equivalent	Organon Teknika Corp.
K993576	BACT/ALERT MP PROCESS BOTTLE	Dec 14, 1999	Substantially Equivalent	Organon Teknika Corp.
K993421	BACT/ALERT SN	Dec 14, 1999	Substantially Equivalent	Organon Teknika Corp.
K992432	BACT/ALERT FN	Sep 24, 1999	Substantially Equivalent	Organon Teknika Corp.
K992401	BACT/ALERT PF	Sep 03, 1999	Substantially Equivalent	Organon Teknika Corp.
K992400	BACTALERT FA	Sep 03, 1999	Substantially Equivalent	Organon Teknika Corp.
K983772	MB/BACT BLOOD CULTURE BOTTLE	Jan 13, 1999	Substantially Equivalent	Organon Teknika Corp.
K982263	MB/BACT BLOOD CULTURE BOTTLE	Aug 18, 1998	Substantially Equivalent	Organon Teknika Corp.
K981736	BACT/ALERT 3D MICROBIAL DETECTION SYSTEM	Jul 24, 1998	Substantially Equivalent	Organon Teknika Corp.
K974883	BACTEC MGIT 960 SYSTEM	May 01, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K970333	BACTEC MYCO/F LYTIC CULTURE VIALS	Jan 28, 1998	Substantially Equivalent	Becton Dickinson Microbiology Systems
K970512	BACTEC MYCO/F LYTIC CULTURE VIALS	Jan 08, 1998	Substantially Equivalent	Becton Dickinson Microbiology Systems
K973325	BACT/ALERT FAN CULTURE BOTTLES	Dec 02, 1997	Substantially Equivalent	Organon Teknika Corp.
K973305	BACT/ALERT CULTURE BOTTLES	Nov 17, 1997	Substantially Equivalent	Organon Teknika Corp.
K972758	BACTEC MYCO/F-SPUTA CULTURE VIALS	Aug 08, 1997	Substantially Equivalent	Becton Dickinson Microbiology Systems
K972756	MODIFICATION OF EST CULTURE SYSTEM II - MYCO	Aug 01, 1997	Substantially Equivalent	Accumed Intl., Inc.
K954932	BBL MGIT PRODUCTS	Aug 21, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K962210	BACTEC 9050 SYSTEM	Aug 08, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954468	MB/BACT MYCROBACTERIA DETECTION SYSTEM	Jul 22, 1996	Substantially Equivalent	Organon Teknika Corp.
K946268	BACTEC(R) 9000TB SYSTEM	May 21, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954930	BACTEC CULTURE VIALS, LYTIC, ANAEROBIC	Feb 16, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954927	BACTEC PEDS PLUS/F CULTURE VIALS	Feb 16, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954925	BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS	Feb 16, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954921	BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS	Feb 16, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K954924	BACTEC PEDS PLUS CLUTURE VIALS	Feb 08, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K953129	ESP CULTURE SYSTEM - MYCO	Dec 26, 1995	Substantially Equivalent	Difco Laboratories, Inc.
K944594	BACT/ALERT FAN CULTURE BOTTLE	Feb 17, 1995	Substantially Equivalent	Organon Teknika Corp.
K935711	BACT/ALERT FAN AEROBIC CULTURE BOTTLE	Aug 30, 1994	Substantially Equivalent	Organon Teknika Corp.
K934593	BACT/ALERT 120	Feb 09, 1994	Substantially Equivalent	Organon Teknika Corp.
K926304	BACTEC PEDS PLUS/F	Mar 04, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K925693	EZ VIEW	Jan 15, 1993	Substantially Equivalent	Difco Laboratories, Inc.
K921637	ESP BLOOD CULTURE SYSTEM	Jul 14, 1992	Substantially Equivalent	Difco Laboratories, Inc.
K922475	BACTEC 9120 SYSTEM	Jul 01, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920249	BACT/ALERT PEDI-BACT	Apr 23, 1992	Substantially Equivalent	Organon Teknika Corp.
K921133	BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA	Apr 22, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K915796	BACTEC 9240 SYSTEM	Apr 22, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920933	BACTEC FOS CULTURE SUPPLEMENT	Apr 17, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K903505	BACT/ALERT (TM)	Mar 12, 1991	Substantially Equivalent	Organon Teknika Corp.
K833888	PENASE	Jan 03, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K812315	BACTEC RESIN CULTURE MED. 16A	Nov 10, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K810613	ANTIMICROBIAL REMOVAL DEVICE	Apr 03, 1981	Substantially Equivalent	Marion Laboratories, Inc.