510(k) Report

FDA applicant

Accelerate Diagnotics

Tucson, AZ1 decision2017–20170 recalls

FDA records 1 decision for Accelerate Diagnotics (Tucson, AZ) in 2017: 1 De Novo grant. All are in product code PRH (Positive Blood Culture Identification And Ast…). No recall is linked to its devices.

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 Accelerate Diagnotics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Accelerate Diagnotics by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PRHPositive Blood Culture Identification And Ast Kit1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • DEN160032Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 20174cite it

What has FDA decided for it lately?

  • DEN160032Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017

The one decision as Accelerate Diagnotics →

Other applicant names beginning “Accelerate”

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

Accelerate Diagnostics, Inc. 2