Cleared Traditional

K253887 - Nasal Alar SpO2 Sensor (989803205381) (FDA 510(k) Clearance)

Also includes:
Nasal Alar SpO2 Sensor (989803205391) Nasal Alar Sp02 Sensor (989803205401)

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

K253887 · Philips Medizin Systeme · Anesthesiology device
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May 2026
Decision
148d
Days
Class 2
Risk

K253887 is an FDA 510(k) clearance for the Nasal Alar SpO2 Sensor (989803205381). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medizin Systeme (Boblingen, DE). The FDA issued a Cleared decision on May 1, 2026 after a review of 148 days - within the typical 510(k) review window.

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 Philips Medizin Systeme devices

Submission Details

510(k) Number K253887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date May 01, 2026
Days to Decision 148 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
9d slower than avg
Panel avg: 139d · This submission: 148d
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 Peers - DQA Oximeter

All 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K253887.
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
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · Unimed Medical Supplies, Inc. · Dec 2025