Cleared Special

K030973 - PICOSAT II SPO2 PULSE OXIMETRY MODULE

K030973 is an FDA 510(k) clearance for PICOSAT II SPO2 PULSE OXIMETRY MODULE, manufactured by Philips Medical Systems. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 117-day FDA review.

K030973 · Philips Medical Systems · Anesthesiology device
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Jul 2003
Decision
117d
Days
Class 2
Risk

K030973 is an FDA 510(k) clearance for the PICOSAT II SPO2 PULSE OXIMETRY MODULE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 23, 2003 after a review of 117 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 devices

FDA 510(k) Submission Details - K030973

510(k) Number K030973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date July 23, 2003
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K030973.
DRAEGER MICRO2+ AND MASIMO MINISAT
K032537 · Draeger Medical Systems, Inc. · Nov 2003
MODEL 3100 WRISTOX PULSE OXIMETER
K030668 · Nonin Medical, Inc. · Oct 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · Nonin Medical, Inc. · Jul 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
K030930 · Nellcor Puritan Bennett, Inc. · May 2003
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K031330 · Masimo Corp. · May 2003