Cleared Special

K032979 - PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T

K032979 is an FDA 510(k) clearance for PHILIPS SPO2 REUSABLE SENSORS, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 149-day FDA review.

K032979 · Philips Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
149d
Days
Class 2
Risk

K032979 is an FDA 510(k) clearance for the PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Boblingen, DE). The FDA issued a Cleared decision on February 20, 2004 after a review of 149 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.

FDA 510(k) Submission Details - K032979

510(k) Number K032979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date February 20, 2004
Days to Decision 149 days
Submission Type Special
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: 140d · This submission: 149d
Pathway characteristics
Modification to existing cleared device.

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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032979.
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
K033998 · Masimo Corp. · Mar 2004
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
K033876 · Dolphin Medical, Inc. · Mar 2004
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K040214 · Masimo Corp. · Feb 2004
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
K032551 · Masimo Corp. · Feb 2004
MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5
K033296 · Masimo Corp. · Feb 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · Philips Medical Systems, Inc. · Feb 2004
K032979 · PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
Download PDF FDA Summary Philips Medical Syste…