510(k) Report

FDA applicant

Q3 Innovations, LLC

Deer Field, IL2 decisions2005–20080 recalls

FDA records 2 decisions for Q3 Innovations, LLC (Deer Field, IL) from 2005 to 2008: 2 510(k) clearances. All are in product code DJZ (Devices, Breath Trapping, Alcohol). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, clinical toxicology panel, where it files most

How often FDA has decided Q3 Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Q3 Innovations, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Q3 Innovations, LLC’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?

  • DJZDevices, Breath Trapping, Alcohol2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K080848Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 20084cite it
  • K043188Alcohawk PrecisionQ3 Innovations, LLC · 20052cite it

What has FDA decided for it lately?

  • K080848Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008
  • K043188Alcohawk PrecisionQ3 Innovations, LLC · 2005

All 2 as Q3 Innovations, LLC →