Cleared Abbreviated

K042306 - PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A

K042306 is an FDA 510(k) clearance for PHILIPS SP02 DISPOSABLE SENSOR, manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Abbreviated 510(k) pathway after a 51-day FDA review.

K042306 · Philips Medizin Systeme Boeblingen GmbH · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Oct 2004
Decision
51d
Days
Class 2
Risk

K042306 is an FDA 510(k) clearance for the PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on October 15, 2004 after a review of 51 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medizin Systeme Boeblingen GmbH devices

FDA 510(k) Submission Details - K042306

510(k) Number K042306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2004
Decision Date October 15, 2004
Days to Decision 51 days
Submission Type Abbreviated
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
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Standards-based clearance path.

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 602
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K042306.
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K042704 · Elekon Industries U.S.A., Inc. · Nov 2004
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K042501 · Hitachi Medical Corp. · Oct 2004
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
K041522 · Elekon Industries U.S.A., Inc. · Sep 2004