Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

bioMerieux, Inc. · Predicate Candidate Screening

253 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

59 daysmedian FDA review time
265 days90th percentile
253clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.2026-07-081690
K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026-04-15760
K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.2025-08-21900
K234012VITEK COMPACT PRObioMerieux, Inc.2025-03-144510
K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.2024-06-122650
K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.2024-06-072600
K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.2024-05-01900
K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc.2024-03-11840
K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VbioMerieux, Inc.2023-10-23900
K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VbioMerieux, Inc.2023-07-05980
K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mLbioMerieux, Inc.2023-06-263250
K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VIbioMerieux, Inc.2023-02-16900
K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc.2023-02-092100
K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.2023-02-03770
K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VbioMerieux, Inc.2023-01-273150
K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc.2022-10-132090
K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.2022-08-083850
K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2bioMerieux, Inc.2022-07-122100
K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.2022-06-031690
K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc.2022-04-141130
K212461VITEK MS PRIMEbioMerieux, Inc.2022-03-152210
K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 ASbioMerieux, Inc.2022-02-251480
K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)Biomérieux, Inc.2022-02-041500
K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)bioMerieux, Inc.2021-10-282680
K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc.2021-09-143890
K211630VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =bioMerieux, Inc.2021-08-30950
K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc.2021-07-093850
K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16bioMerieux, Inc.2021-06-14591
K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)bioMerieux, Inc.2020-09-283060
K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.2020-04-28530
K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=bioMerieux, Inc.2020-03-13810
K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)bioMerieux, Inc.2020-02-14531
K192110Vitek DensichekbioMerieux, Inc.2019-10-31870
K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc.2019-08-05350
K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mLbioMerieux, Inc.2019-06-06870
K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.2019-05-15850
K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc.2019-03-12830
K183551VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)bioMerieux, Inc.2019-03-07770
K183360VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >bioMerieux, Inc.2019-02-26841
K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.2019-02-20721
K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.2019-02-11880
K181412VITEK MSbioMerieux, Inc.2018-12-212050
K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.2018-12-101600
K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc.2018-06-20280
K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLbioMerieux, Inc.2017-12-19841
K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.2017-12-08880
K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)bioMerieux, Inc.2017-09-15601
K162950VITEK MSbioMerieux, Inc.2017-07-222710
K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, Inc.2017-06-212640
K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc.2017-05-31861

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda