Cleared Abbreviated

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A (K042306) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K042306 · Philips Medizin Systeme Boeblingen GmbH · Anesthesiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 139d · This submission: 51d
Pathway characteristics
Standards-based clearance path.

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 147
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