Not Cleared Direct

DEN210039 - SNOO Smart Sleeper (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210039 · Happiest Baby, Inc. · General Hospital
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Mar 2023
Decision
556d
Days
Class 2
Risk

DEN210039 is an FDA 510(k) submission (not cleared) for the SNOO Smart Sleeper. Classified as Infant Supine Sleep System (product code QTG), Class II - Special Controls.

Submitted by Happiest Baby, Inc. (Los Angeles, US). The FDA issued a Not Cleared (DENG) decision on March 30, 2023 after a review of 556 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5690 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 556 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Happiest Baby, Inc. devices

Submission Details

510(k) Number DEN210039 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 20, 2021
Decision Date March 30, 2023
Days to Decision 556 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
428d slower than avg
Panel avg: 128d · This submission: 556d
Pathway characteristics

Device Classification

Product Code QTG Infant Supine Sleep System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5690
Definition 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 Infant Death Syndrome (sids) Or Sudden Unexpected Infant Death (suid).
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 General Hospital devices follow this clearance model.