Cleared Special

K032979 - PHILIPS SPO2 REUSABLE SENSORS

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

K032979 · Philips Medical Systems, Inc. · Anesthesiology device
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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.

View all Philips Medical Systems, Inc. devices

Submission Details

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.

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 384
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032979.
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
K041156 · Nonin Medical, Inc. · Jun 2004
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NVISION DATA MANAGEMENT SOFTWARE
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K033715 · Philips Medical Systems, Inc. · Feb 2004
DRAEGER MICRO2+ AND MASIMO MINISAT
K032537 · Draeger Medical Systems, Inc. · Nov 2003
MODEL 3100 WRISTOX PULSE OXIMETER
K030668 · Nonin Medical, Inc. · Oct 2003