Cleared Special

K090360 - PHILIPS M3001A MULTI MEASUREMENT SERVER

K090360 is an FDA 510(k) clearance for PHILIPS M3001A MULTI MEASUREMENT SERVER, manufactured by Philips Medizin Systeme Boblingen GmbH. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 81-day FDA review.

K090360 · Philips Medizin Systeme Boblingen GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
81d
Days
Class 2
Risk

K090360 is an FDA 510(k) clearance for the PHILIPS M3001A MULTI MEASUREMENT SERVER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on May 4, 2009 after a review of 81 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 Medizin Systeme Boblingen GmbH devices

FDA 510(k) Submission Details - K090360

510(k) Number K090360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2009
Decision Date May 04, 2009
Days to Decision 81 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K090360.
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
K090165 · Masimo Corporation · Jul 2009
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · Masimo Corporation · Jul 2009
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · Beijing Choice Electronic Technololgy Co., Ltd. · Apr 2009
LNCS OXIMETRY SENSORS
K083622 · Masimo Corporation · Apr 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · Cas Medical Systems, Inc. · Mar 2009