510(k) Report

FDA applicant

Sleep Performance D.B.A. Fatigue Science

Irvine, CA1 decision2011–20110 recalls

FDA records 1 decision for Sleep Performance D.B.A. Fatigue Science (Irvine, CA) in 2011: 1 510(k) clearance. All are in product code LEL (Device, Sleep Assessment). 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, neurology panel, where it files most

How often FDA has decided Sleep Performance D.B.A. Fatigue Science’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Sleep Performance D.B.A. Fatigue Science by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LELDevice, Sleep Assessment1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K111514SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science · 20112cite it

What has FDA decided for it lately?

  • K111514SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science · 2011

The one decision as Sleep Performance D.B.A. Fatigue Science →

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 Devices, Inc. 1