510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111514Substantially Equivalent

Sbv2, Multicharger Model Mc10v2

Sleep Performance D.B.A. Fatigue Science, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111514 is the FDA 510(k) clearance record for SBV2, MULTICHARGER MODEL MC10V2, a class II device, cleared for Sleep Performance D.B.A. Fatigue Science on under FDA product code LEL (Device, Sleep Assessment). FDA records list one 510(k) clearance for Sleep Performance D.B.A. Fatigue Science. As of , FDA records show no recalls naming K111514.

Clearance record

Decision date
Received
(198 days to decision)
Product code
LEL Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Sleep Performance D.B.A. Fatigue Science 5405 Alton Pkwy., Suite A530, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LEL

Trailing 12 months
1 clearance under product code LEL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LEL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260