MDB · Class I · 21 CFR 866.2560

FDA Product Code MDB: System, Blood Culturing

Leading manufacturers include Organon Teknika Corp., bioMerieux, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

68
Total
68
Cleared
122d
Avg days
1981
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 125d avg (recent)

FDA 510(k) Cleared System, Blood Culturing Devices (Product Code MDB)

68 devices
1–24 of 68
Cleared May 28, 2026
BD BACTEC FXI Culture System
K260213
Bd Diagnostic Systems
Microbiology · 125d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559
Becton, Dickinson and Company
Microbiology · 212d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591
Becton, Dickinson and Company
Microbiology · 210d
Cleared May 15, 2019
BACT/ALERT MP Reagent System
K190405
bioMerieux, Inc.
Microbiology · 85d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166
bioMerieux, Inc.
Microbiology · 88d
Cleared Mar 16, 2018
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
K173873
Becton, Dickinson and Company
Microbiology · 86d
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816
bioMerieux, Inc.
Microbiology · 270d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866
Becton, Dickinson and Company
Microbiology · 231d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810
Becton, Dickinson and Company
Microbiology · 156d
Cleared May 13, 2013
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903
Becton, Dickinson & CO
Microbiology · 145d
Cleared Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446
bioMerieux, Inc.
Microbiology · 255d
Cleared Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455
bioMerieux, Inc.
Microbiology · 254d
Cleared Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461
bioMerieux, Inc.
Microbiology · 250d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994
Becton, Dickinson and Company
Microbiology · 127d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558
Becton, Dickinson and Company
Microbiology · 106d
Cleared Dec 24, 2008
BD BACTEC Plus Aerobic/F Culture Vials
K083572
Becton, Dickinson & CO
Microbiology · 21d
Cleared Aug 22, 2003
VERSATREK
K032306
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Jul 14, 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737
bioMerieux, Inc.
Microbiology · 40d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815
bioMerieux, Inc.
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923
bioMerieux, Inc.
Microbiology · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931
bioMerieux, Inc.
Microbiology · 27d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813
bioMerieux, Inc.
Microbiology · 35d
Cleared Mar 02, 2000
BACT/ALERT MB CULTURE BOTTLE
K000378
Organon Teknika Corp.
Microbiology · 24d

About Product Code MDB - Regulatory Context

510(k) Submission Activity

68 total 510(k) submissions under product code MDB since 1981, with 68 receiving FDA clearance (average review time: 122 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - MDB Product Code

FDA review times for MDB submissions have been consistent, averaging 125 days recently vs 122 days historically.

MDB devices are reviewed by the Microbiology panel. Browse all Microbiology devices →