510(k) Report

FDA applicant

Khn Solutions, LLC

Deer Field, IL4 decisions2004–20090 recalls

FDA records 4 decisions for Khn Solutions, LLC (Deer Field, IL) from 2004 to 2009: 4 510(k) clearances. All are in product code DJZ (Devices, Breath Trapping, Alcohol). Its devices cite 3 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 Khn Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007: 12009: 2
2007high 2 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Khn Solutions, 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, Alcohol4decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K041334Alcomate, Model CA2000Khn Solutions, LLC · 20047cite it

What has FDA decided for it lately?

  • K090067Bactrack Select Breathalyzer, Model S80Khn Solutions, LLC · 2009
  • K083801Bactrack Select Breathalyzer, Models S30, S50, S70Khn Solutions, LLC · 2009
  • K071067Bactrack LCD Alcohol DetectorKhn Solutions, LLC · 2007
  • K041334Alcomate, Model CA2000Khn Solutions, LLC · 2004

All 4 as Khn Solutions, LLC →