Atlas FDA

LON

289 FDA 510(k) clearances · Product code

58 daysmedian time to decision
220 days90th percentile
289clearances measured

FDA profile

Official device name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1645
Medical specialty
Microbiology
Adverse events (MAUDE)
2021: 232 · 2022: 180 · 2023: 453 · 2024: 418 · 2025: 699 · 2026: 404
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)bioMerieux, Inc.2026-04-15
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)BIOMERIEUX2026-03-26
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)bioMerieux, Inc.2025-08-21
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713)Becton, Dickinson and Company2025-08-08
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447)Becton, Dickinson and Company2025-05-19
VITEK COMPACT PRO (K234012)bioMerieux, Inc.2025-03-14
BD Phoenix™ Automated Microbiology System (K250344)Becton, Dickinson and Company2025-03-06
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986)Becton, Dickinson and Company2024-03-15
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
Colibrí (K232756)Copan Wasp Srl2023-12-27
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201)bioMerieux, Inc.2023-10-23
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864)bioMerieux, Inc.2023-07-05
VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (K222378)bioMerieux, Inc.2023-06-26
Selux AST System; Model AST Gen 1.0 (K211748)Selux Diagnostics, Inc.2023-04-19
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)Biomerieux Sa, Inc.2023-03-09
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)bioMerieux, Inc.2023-02-16
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)bioMerieux, Inc.2023-02-09
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481)bioMerieux, Inc.2023-02-03
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803)bioMerieux, Inc.2023-01-27
Selux AST System; Model AST Gen 1.0 (K211759)Selux Diagnostics, Inc.2023-01-18
VITEK 2 AST-Gram Positive Cefoxitin Screen (K220805)bioMerieux, Inc.2022-10-13
Colibrí System (K220546)Copan Wasp Srl2022-10-05
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) (K212243)bioMerieux, Inc.2022-08-08
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (K213899)bioMerieux, Inc.2022-07-12
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (K213931)bioMerieux, Inc.2022-06-03
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) (K214023)bioMerieux, Inc.2022-04-14
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (K213241)bioMerieux, Inc.2022-02-25
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) (K212849)Biomérieux, Inc.2022-02-04
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) (K210287)bioMerieux, Inc.2021-10-28
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (K202396)bioMerieux, Inc.2021-09-14
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (K211630)bioMerieux, Inc.2021-08-30
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) (K201675)bioMerieux, Inc.2021-07-09
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (K211136)bioMerieux, Inc.2021-06-14
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) (K193299)bioMerieux, Inc.2020-09-28
LabPro Data Management System (K201405)Beckman Coulter, Inc.2020-08-30
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (K200590)bioMerieux, Inc.2020-04-28
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (K193572)bioMerieux, Inc.2020-03-13
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) (K193567)bioMerieux, Inc.2020-02-14
Vitek Densichek (K192110)bioMerieux, Inc.2019-10-31
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (K191766)bioMerieux, Inc.2019-08-05
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) (K190905)Becton, Dickinson and Company2019-07-01
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) (K190616)bioMerieux, Inc.2019-06-06
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) (K183524)bioMerieux, Inc.2019-03-12
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) (K183551)bioMerieux, Inc.2019-03-07
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) (K183360)bioMerieux, Inc.2019-02-26
VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (K183415)bioMerieux, Inc.2019-02-20
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (K181766)bioMerieux, Inc.2018-12-10
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN (K181665)Becton, Dickinson and Company2018-09-21
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) (K173523)Becton, Dickinson and Company2018-02-09
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (K173252)Becton, Dickinson and Company2018-01-05
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL (K172944)bioMerieux, Inc.2017-12-19
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (K172731)bioMerieux, Inc.2017-12-08
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) (K162737)bioMerieux, Inc.2017-06-21
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) (K163637)Becton Dickinson & Company2017-03-21
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) (K163563)bioMerieux, Inc.2017-03-13
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) (K161437)bioMerieux, Inc.2017-02-16
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) (K161510)bioMerieux, Inc.2017-02-13
VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) (K163083)bioMerieux, Inc.2017-02-01
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) (K163006)bioMerieux, Inc.2017-01-24
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) (K161217)bioMerieux, Inc.2017-01-12
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (K161227)bioMerieux, Inc.2016-07-20
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) (K152075)bioMerieux, Inc.2016-04-15
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml (K151320)Becton, Dickinson and Company2016-01-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP (K142170)Becton, Dickinson and Company2014-10-28
VITEK 2 AST GP CEFTAROLINE (K141149)bioMerieux, Inc.2014-06-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) (K140468)Becton, Dickinson and Company2014-06-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) (K132909)Becton, Dickinson and Company2014-02-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) (K132674)Becton, Dickinson and Company2013-12-27
VITEK 2 AST ST MEROPENEM (K132507)bioMerieux, Inc.2013-11-15
VITEK 2 AST-ST TIGECYCLINE (K131779)bioMerieux, Inc.2013-10-10
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN (K132573)bioMerieux, Inc.2013-09-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) (K131331)Becton, Dickinson & CO2013-07-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) (K123404)Becton, Dickinson & CO2013-06-27
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN (K123266)Becton, Dickinson and Company2013-06-26
VITEK 2 GRAM NEGATIVE DOXYCYCLINE (K121546)bioMerieux, Inc.2012-11-20
VITEK 2 AST STREPTOCOCUS VANCOMYCIN (K121100)bioMerieux, Inc.2012-11-19
GRAM POSTITVE CLINDAMYCIN (K122547)bioMerieux, Inc.2012-10-15
VITEK 2 STRPTOCOCCUS CEFTRIAXONE (K122359)bioMerieux, Inc.2012-08-28
VITEK 2 AST-ST CEFOTAXIME (K121863)bioMerieux, Inc.2012-08-16
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K113783)bioMerieux, Inc.2012-08-07
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM (K113200)bioMerieux, Inc.2012-06-29
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE (K111893)bioMerieux, Inc.2012-02-28
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN (K111976)bioMerieux, Inc.2012-02-17
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE (K113305)bioMerieux, Inc.2012-02-10
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE (K110106)bioMerieux, Inc.2011-11-30
VITEK 2 STREPTOCOCCUS PENICILLIN (K112000)bioMerieux, Inc.2011-10-26
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE (K111909)bioMerieux, Inc.2011-10-18
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE (K103752)bioMerieux, Inc.2011-10-14
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN (K112228)bioMerieux, Inc.2011-10-03
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN (K112129)bioMerieux, Inc.2011-09-27
VITEK 2 STRPTOCOCCUS AMPICILLIN (K112075)bioMerieux, Inc.2011-09-15
VITEK 2 AST-ST LINEZOLID (K111599)bioMerieux, Inc.2011-08-12
VITEK 2 GRAM POSITIVE DOXCYCLINE (K093076)bioMerieux, Inc.2010-10-21
DENSICHECK PLUS (K093224)bioMerieux, Inc.2009-11-09
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919)Siemens Healthcare Diagnostics2009-10-23
DENSICHEK PLUS (K083536)bioMerieux, Inc.2009-09-11
VITEK 2 GRAM NEGATIVE MEROPENEM (K091899)bioMerieux, Inc.2009-08-14
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K091126)bioMerieux, Inc.2009-06-18
VITEK 2 GRAM NEGATIVE DORIPENEM (K082346)bioMerieux, Inc.2009-03-16
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K083383)bioMerieux, Inc.2009-02-18
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