510(k) Report

FDA applicant

Sleep Specialists, LLC

Greenville, DE1 decision2010–20100 recalls

FDA records 1 decision for Sleep Specialists, LLC (Greenville, DE) in 2010: 1 510(k) clearance. All are in product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). Its devices cite 2 predicates, 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, dental panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Sleep Specialists, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MYBPillow, Cervical (For Mild Sleep Apnea)1decision

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 1 time; 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.

  • K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 20101cites it

What has FDA decided for it lately?

  • K100160Zzoma Positional Sleeper Model 001Sleep Specialists, LLC · 2010

The one decision as Sleep Specialists, 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 Medicine Network, Inc. 1Sleep Specialties, LLC 1Sleep Group Solutions 1Sleep Renewal, Inc. 1Sleep Modus, Inc. 1Sleep Devices, Inc. 1Sleep Performance D.B.A. Fatigue Science 1