510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140032Unknown

Cereve Sleep System

Cereve, Inc., Oakmont PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140032 is the FDA 510(k) clearance record for Cereve Sleep System, a class II device, cleared for Cereve, Inc. on under FDA product code PLU (Thermal System For Insomnia). FDA's definition for product code PLU reads: "A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface". FDA records list one 510(k) clearance for Cereve, Inc. As of , FDA records show no recalls naming DEN140032.

Clearance record

Decision date
Received
(571 days to decision)
Product code
PLU Thermal System For Insomnia
Regulation
21 CFR 882.5700
Device class
Class II
Review panel
Neurology
Applicant
Cereve, Inc. 333 Allegheny Ave., 2nd Floor N., Oakmont PA
Third party review
No

Clearances, product code PLU

Trailing 12 months

FDA records hold no clearances under product code PLU in the trailing twelve months.

FDA records show no clearances under product code PLU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260