510(k) Report

FDA applicant

bioMerieux, Inc.

Hazelwood, MO283 decisions1983–2026163 recalls

FDA records 283 decisions for bioMerieux, Inc. (Hazelwood, MO) from 1983 to 2026: 279 510(k) clearances, 1 De Novo grant and 3 original PMA approvals. Most are in product codes LON (System, Test, Automated, Antimicrobial…) and JSJ (Culture Media, Selective And Non-Differential). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 176 predicates, 135 of them its own earlier devices. 163 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Biomerieux S.A.”, “BIOMERIEUX”, “Biomérieux”, “Biomérieux, Inc.”, “Biomérieux SA”, “Biomerieux Sa, Inc.”, “bioMérieux SA”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided bioMerieux, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2007: 92008: 92009: 102010: 62011: 112012: 122013: 112014: 32015: 32016: 72017: 162018: 52019: 142020: 52021: 62022: 92023: 92024: 42025: 42026 (partial year): 6
2007high 16 (2017) · low 3 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 12010: 1122011: 42012: 12013: 22014: 52015: 12016: 22017: 32018: 3, 1 Class I2019: 12020: 12021: 42022: 202024: 1, 1 Class I2026 (partial year): 1
2007high 112 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — bioMerieux, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like bioMerieux, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation118decisions
  • JSJCulture Media, Selective And Non-Differential18decisions
  • JWYManual Antimicrobial Susceptibility Test Systems18decisions
  • JSGCulture Media, Non-Selective And Non-Differential13decisions
  • MDBSystem, Blood Culturing12decisions
  • JSHCulture Media, Non-Selective And Differential12decisions

Also: JSI (11), NGZ (10), JSF (7), JSO (5), DAP (4), KZI (3).

How long do its 510(k) reviews take?

Since 2016, its 67 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 31 of its 67 were faster than that.

Whose devices does it build on?

Its devices cite 176 predicates; 135 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 165 times; 135 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 200712cite it
  • K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 20049cite it
  • K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 20127cite it
  • K162827Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 20176cite it
  • K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc. · 20195cite it
  • K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 20074cite it

What has FDA decided for it lately?

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
  • K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)Biomérieux · 2025

All 256 as bioMerieux, Inc. →All 16 as Biomerieux S.A. →All 3 as Biomerieux →

What has been recalled?

163 recalls linked to its devices; the latest:

  • K172944VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o…Jan 5, 2026Class II
  • K161217VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial…Mar 14, 2024Class I
  • K091025PPM Clinical Craponne Chromid Vre 20 PLT US, Catalog 43851Nov 9, 2022Class II
  • K032399Vitek 2 Reagent Ast-GP67 Test Kit 20 Cards, Catalog 22226Nov 9, 2022Class II
  • K181092PPM Industry Combourg Chromid Carba US 20 PLT, Catalog 414012Nov 9, 2022Class II
  • K032399Vitek 2 Reagent Ast-GP75 Test Kit 20 Cards, Catalog 415670Nov 9, 2022Class II

Other applicant names beginning “bioMerieux”

FDA records each applicant name separately; these may or may not be the same firm.

Biomerieux Vitek, Inc. 50