Atlas FDA

MDB

68 FDA 510(k) clearances · Product code

89 daysmedian time to decision
270 days90th percentile
68clearances measured

FDA profile

Official device name
System, Blood Culturing
Device class
Class I (low risk)
Regulation
21 CFR 866.2560
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 1,184 · 2022: 643 · 2023: 1,232 · 2024: 401 · 2025: 1,983 · 2026: 193
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BD BACTEC FXI Culture System (K260213)BD Diagnostic Systems2026-05-28
BD BACTEC™ Plus Aerobic/F Culture Vials (K222591)Becton, Dickinson and Company2023-03-24
BD BACTEC™ Myco/F Lytic Culture Vials (K222559)Becton, Dickinson and Company2023-03-24
BACT/ALERT MP Reagent System (K190405)bioMerieux, Inc.2019-05-15
BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166)bioMerieux, Inc.2019-02-11
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873)Becton, Dickinson and Company2018-03-16
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816)bioMerieux, Inc.2017-03-28
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810)Becton Dickinson2017-02-09
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306)Becton Dickinson2016-08-08
BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866)Becton, Dickinson and Company2016-02-25
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903)Becton, Dickinson & CO2013-05-13
BACT/ALERT FN PLUS CULTURE BOTTLE (K121455)bioMerieux, Inc.2013-01-25
BACT/ALERT PF PLUS CULTURE BOTTLE (K121446)bioMerieux, Inc.2013-01-25
BACT/ALERT FA PLUS CULTURE BOTTLE (K121461)bioMerieux, Inc.2013-01-22
BD BACTEC Plus PRIME Aerobic/F Culture Vials (K120994)Becton, Dickinson and Company2012-08-07
BD BACTEC Plus Aerobic/F Culture Vials (plastic) (K113558)Becton, Dickinson and Company2012-03-16
BD BACTEC Plus Aerobic/F Culture Vials (K083572)Becton, Dickinson & CO2008-12-24
VERSATREK (K032306)Trek Diagnostic Systems, Inc.2003-08-22
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) (K031737)bioMerieux, Inc.2003-07-14
BACT/ALERT SN CULTURE BOTTLE (K021123)bioMerieux, Inc.2002-04-26
BACT/ALERT FN CULTURE BOTTLE (K020815)bioMerieux, Inc.2002-04-18
BACT/ALERT PF CULTURE BOTTLE (K020923)bioMerieux, Inc.2002-04-18
BACT/ALERT SA CULTURE BOTTLE (K020931)bioMerieux, Inc.2002-04-18
BACT/ALERT FA CULTURE BOTTLE (K020813)bioMerieux, Inc.2002-04-17
BACT/ALERT MB CULTURE BOTTLE (K000378)Organon Teknika Corp.2000-03-02
BACT/ALERT SV (K994343)Organon Teknika Corp.2000-02-10
BACT/ALERT SA (K993423)Organon Teknika Corp.1999-12-15
BACT/ALERT SN (K993421)Organon Teknika Corp.1999-12-14
BACT/ALERT MP PROCESS BOTTLE (K993576)Organon Teknika Corp.1999-12-14
BACT/ALERT FN (K992432)Organon Teknika Corp.1999-09-24
BACT/ALERT PF (K992401)Organon Teknika Corp.1999-09-03
BACTALERT FA (K992400)Organon Teknika Corp.1999-09-03
MB/BACT BLOOD CULTURE BOTTLE (K983772)Organon Teknika Corp.1999-01-13
MB/BACT BLOOD CULTURE BOTTLE (K982263)Organon Teknika Corp.1998-08-18
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM (K981736)Organon Teknika Corp.1998-07-24
BACTEC MGIT 960 SYSTEM (K974883)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-05-01
BACTEC MYCO/F LYTIC CULTURE VIALS (K970333)Becton Dickinson Microbiology Systems1998-01-28
BACTEC MYCO/F LYTIC CULTURE VIALS (K970512)Becton Dickinson Microbiology Systems1998-01-08
BACT/ALERT FAN CULTURE BOTTLES (K973325)Organon Teknika Corp.1997-12-02
BACT/ALERT CULTURE BOTTLES (K973305)Organon Teknika Corp.1997-11-17
BACTEC MYCO/F-SPUTA CULTURE VIALS (K972758)Becton Dickinson Microbiology Systems1997-08-08
MODIFICATION OF EST CULTURE SYSTEM II - MYCO (K972756)Accumed Intl., Inc.1997-08-01
BBL MGIT PRODUCTS (K954932)Becton Dickinson Diagnostic Instrument Systems1996-08-21
BACTEC 9050 SYSTEM (K962210)Becton Dickinson Diagnostic Instrument Systems1996-08-08
MB/BACT MYCROBACTERIA DETECTION SYSTEM (K954468)Organon Teknika Corp.1996-07-22
BACTEC(R) 9000TB SYSTEM (K946268)Becton Dickinson Diagnostic Instrument Systems1996-05-21
BACTEC PEDS PLUS/F CULTURE VIALS (K954927)Becton Dickinson Diagnostic Instrument Systems1996-02-16
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC (K954930)Becton Dickinson Diagnostic Instrument Systems1996-02-16
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS (K954921)Becton Dickinson Diagnostic Instrument Systems1996-02-16
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (K954925)Becton Dickinson Diagnostic Instrument Systems1996-02-16
BACTEC PEDS PLUS CLUTURE VIALS (K954924)Becton Dickinson Diagnostic Instrument Systems1996-02-08
ESP CULTURE SYSTEM - MYCO (K953129)Difco Laboratories, Inc.1995-12-26
BACT/ALERT FAN CULTURE BOTTLE (K944594)Organon Teknika Corp.1995-02-17
BACT/ALERT FAN AEROBIC CULTURE BOTTLE (K935711)Organon Teknika Corp.1994-08-30
BACT/ALERT 120 (K934593)Organon Teknika Corp.1994-02-09
BACTEC PEDS PLUS/F (K926304)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-03-04
EZ VIEW (K925693)Difco Laboratories, Inc.1993-01-15
ESP BLOOD CULTURE SYSTEM (K921637)Difco Laboratories, Inc.1992-07-14
BACTEC 9120 SYSTEM (K922475)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-01
BACT/ALERT PEDI-BACT (K920249)Organon Teknika Corp.1992-04-23
BACTEC 9240 SYSTEM (K915796)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA (K921133)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
BACTEC FOS CULTURE SUPPLEMENT (K920933)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-17
BACT/ALERT (TM) (K903505)Organon Teknika Corp.1991-03-12
PENASE (K833888)Oxoid U.S.A., Inc.1984-01-03
BACTEC RESIN CULTURE MED. 16A (K812315)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-10
ANTIMICROBIAL REMOVAL DEVICE (K810613)Marion Laboratories, Inc.1981-04-03

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Every clearance here is in the API, with alerts when new ones post.