Cleared Traditional

K111514 - SBV2, MULTICHARGER MODEL MC10V2

K111514 is an FDA 510(k) clearance for SBV2, manufactured by Sleep Performance D.B.A. Fatigue Science. The device is a Class 2 Neurology device with product code LEL cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K111514 · Sleep Performance D.B.A. Fatigue Science · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
198d
Days
Class 2
Risk

K111514 is an FDA 510(k) clearance for the SBV2, MULTICHARGER MODEL MC10V2. Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Sleep Performance D.B.A. Fatigue Science (Irvine, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 198 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sleep Performance D.B.A. Fatigue Science devices

FDA 510(k) Submission Details - K111514

510(k) Number K111514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date December 16, 2011
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEL Device Classification - Class 2, Special Controls

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LEL Device, Sleep Assessment

All 11
Devices cleared under the same product code (LEL) and FDA review panel - the closest regulatory comparables to K111514.
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