Cleared Special

K033715 - PICOSAT II SP02 PULSE OXIMETRY MODULE A...

K033715 is the FDA 510(k) clearance for PICOSAT II SP02 PULSE OXIMETRY MODULE A... by Philips Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 79-day FDA review.

K033715 · Philips Medical Systems, Inc. · Anesthesiology device
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Feb 2004
Decision
79d
Days
Class 2
Risk

K033715 is an FDA 510(k) clearance for the PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER. 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 February 13, 2004 after a review of 79 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K033715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 13, 2004
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 K033715.
MODIFICATION TO AVANT 9600 PULSE OXIMETER
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K032537 · Draeger Medical Systems, Inc. · Nov 2003
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K030668 · Nonin Medical, Inc. · Oct 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · Nonin Medical, Inc. · Jul 2003