MDB · Class I · 21 CFR 866.2560

FDA Product Code MDB: System, Blood Culturing

Leading manufacturers include bioMerieux, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Becton, Dickinson and Company.

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 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 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 May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 122d
Cleared Mar 04, 1993
BACTEC PEDS PLUS/F
K926304
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 79d
Cleared Jul 01, 1992
BACTEC 9120 SYSTEM
K922475
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 36d
Cleared Apr 22, 1992
BACTEC 9240 SYSTEM
K915796
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 120d
Cleared Apr 22, 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 43d
Cleared Apr 17, 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 49d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 85d

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 →