510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210039Unknown

SNOO Smart Sleeper

Happiest Baby, Inc, Los Angeles CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210039 is the FDA 510(k) clearance record for SNOO Smart Sleeper, a class II device, cleared for Happiest Baby, Inc. on under FDA product code QTG (Infant Supine Sleep System). FDA's definition for product code QTG reads: "An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden...". FDA records list one 510(k) clearance for Happiest Baby, Inc. As of , FDA records show no recalls naming DEN210039.

Clearance record

Decision date
Received
(556 days to decision)
Product code
QTG Infant Supine Sleep System
Regulation
21 CFR 880.5690
Device class
Class II
Review panel
General Hospital
Applicant
Happiest Baby, Inc. 3115 S. La Cienega Blvd., Los Angeles CA
Third party review
No

Clearances, product code QTG

Trailing 12 months

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

FDA records show no clearances under product code QTG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTG, 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