510(k) Report

FDA applicant

Soberlink Healthcare, LLC

Huntington Beach, CA1 decision2016–20160 recalls

FDA records 1 decision for Soberlink Healthcare, LLC (Huntington Beach, CA) in 2016: 1 510(k) clearance. All are in product code DJZ (Devices, Breath Trapping, Alcohol). Its devices cite 1 predicate, 0 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 Soberlink Healthcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Soberlink Healthcare, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DJZDevices, Breath Trapping, Alcohol1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC · 2016

The one decision as Soberlink Healthcare, LLC →