510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K190058Substantially Equivalent

PureSleep (OTC use)

Sleep Science Partners, Inc., Larkspur CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190058 is the FDA 510(k) clearance record for PureSleep (OTC use), a class II device, cleared for Sleep Science Partners, Inc. on under FDA product code LRK (Device, Anti-Snoring). FDA records list 2 510(k) clearances for Sleep Science Partners, Inc., from to . As of , FDA records show no recalls naming K190058.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LRK Device, Anti-Snoring
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Sleep Science Partners, Inc. 900 Larkspur Landing Cir. Suite 207, Larkspur CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRK

Trailing 12 months
13 clearances under product code LRK in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LRK, trailing twelve months
MonthClearances
November 20253
December 20252
January 20260
February 20260
March 20262
April 20261
May 20261
June 20262
July 20261
August 20261
September 20260
October 20260