Cleared Traditional

K253887 - Nasal Alar SpO2 Sensor (989803205381)

Also marketed or referenced as:
Nasal Alar SpO2 Sensor (989803205391) Nasal Alar Sp02 Sensor (989803205401)

K253887 is an FDA 510(k) clearance for Nasal Alar SpO2 Sensor (989803205381), manufactured by Philips Medizin Systeme. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K253887 · Philips Medizin Systeme · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K253887

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
8d slower than avg
Panel avg: 140d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K253887.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A)
K252821 · Philips Medizin Systeme B?blingen GmbH · May 2026
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
K252655 · Shenzhen Imdk Medical Technology Co., Ltd. · 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