Not Cleared Direct

DEN220091 - Dream Sock (FDA 510(k) Clearance)

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

DEN220091 · Owlet Babycare, Inc. · Cardiovascular device
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Nov 2023
Decision
329d
Days
Class 2
Risk

DEN220091 is an FDA 510(k) submission (not cleared) for the Dream Sock. Classified as Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use (product code QYU), Class II - Special Controls.

Submitted by Owlet Babycare, Inc. (Lehi, US). The FDA issued a Not Cleared (DENG) decision on November 8, 2023 after a review of 329 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2705 - the FDA cardiovascular device oversight 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 329 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 Owlet Babycare, Inc. devices

Submission Details

510(k) Number DEN220091 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 14, 2022
Decision Date November 08, 2023
Days to Decision 329 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 125d · This submission: 329d
Pathway characteristics

Device Classification

Product Code QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2705
Definition An Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Is A Device That Uses Photoplethysmography To Measure Pulse Rate And Oxygen Saturation In Infants. The Device May Contain Alarms That Alert The Caregiver When Vital Sign(s) Go Outside Preset Threshold(s).
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 Cardiovascular devices follow this clearance model.