510(k) Report

FDA applicant

Sleep Devices, Inc.

Kissimmee, FL1 decision2004–20040 recalls

FDA records 1 decision for Sleep Devices, Inc. (Kissimmee, FL) in 2004: 1 510(k) clearance. All are in product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). 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 Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sleep Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sleep Devices, Inc. by year, 2007–2026Sources: 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

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.

  • K040161Sona PillowSleep Devices, Inc. · 20041cites it

What has FDA decided for it lately?

  • K040161Sona PillowSleep Devices, Inc. · 2004

The one decision as Sleep Devices, Inc. →

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 Specialties, LLC 1Sleep Group Solutions 1Sleep Renewal, Inc. 1Sleep Modus, Inc. 1Sleep Performance D.B.A. Fatigue Science 1