Cleared Special

K063783 - PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (FDA 510(k) Clearance)

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

K063783 · Philips Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
127d
Days
Class 2
Risk

K063783 is an FDA 510(k) clearance for the PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T A.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on April 27, 2007 after a review of 127 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K063783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date April 27, 2007
Days to Decision 127 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 139d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 K063783.
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