510(k) Report

FDA applicant

Accelerate Diagnostics, Inc.

Tucson, AZ2 decisions2020–20242 recalls

FDA records 2 decisions for Accelerate Diagnostics, Inc. (Tucson, AZ) from 2020 to 2024: 2 510(k) clearances. Most are in product codes PRH (Positive Blood Culture Identification And Ast…) and QNJ (Mass Spectrometry, Microorganism…). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2022

2022: 2
2020high 2 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Accelerate Diagnostics, Inc. by year, 2020–2026Sources: 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
  • QNJMass Spectrometry, Microorganism Identification, Blood Culture1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K192665Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · 20202cite it

What has FDA decided for it lately?

  • K240854Accelerate Arc SystemAccelerate Diagnostics, Inc. · 2024
  • K192665Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · 20202 recalls

All 2 as Accelerate Diagnostics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K192665Accelerate PhenoTest BC kit REF 10102018Oct 17, 2022Class II
  • K192665Accelerate PhenoTest BC kit REF 10101018Oct 17, 2022Class II

Other applicant names beginning “Accelerate”

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

Accelerate Diagnotics 1