510(k) Report

FDA applicant

Sleep Specialties, LLC

Las Vegas, NV1 decision2018–20180 recalls

FDA records 1 decision for Sleep Specialties, LLC (Las Vegas, NV) in 2018: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). 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

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

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Sleep Specialties, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter1decision

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?

  • K172452BruxorSleep Specialties, LLC · 2018

The one decision as Sleep Specialties, LLC →

Other applicant names beginning “Sleep”

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

Sleep Science Partners, Inc. 2Sleep Solutions, Inc. 2Sleep Specialists, LLC 1Sleep Medicine Network, Inc. 1Sleep Group Solutions 1Sleep Renewal, Inc. 1Sleep Modus, Inc. 1Sleep Devices, Inc. 1Sleep Performance D.B.A. Fatigue Science 1