Cleared Traditional

K222597 - BabySat 3 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222597 · Owlet Babycare, Inc. · Anesthesiology device
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Jun 2023
Decision
291d
Days
Class 2
Risk

K222597 is an FDA 510(k) clearance for the BabySat 3. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Owlet Babycare, Inc. (Lehi, US). The FDA issued a Cleared decision on June 16, 2023 after a review of 291 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Owlet Babycare, Inc. devices

Submission Details

510(k) Number K222597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2022
Decision Date June 16, 2023
Days to Decision 291 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 139d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K222597.
Nasal Alar SpO2 Sensor (989803205381)
K253887 · Philips Medizin Systeme · May 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
K260931 · Unimed Medical Supplies, Inc. · Apr 2026
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025