Cleared Special

K081937 - PICOSAT II AND M3002A MULTIMEASUREMENT ...

K081937 is the FDA 510(k) clearance for PICOSAT II AND M3002A MULTIMEASUREMENT ... by Philips Medizin Systeme Boeblingen GmbH. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 53-day FDA review.

K081937 · Philips Medizin Systeme Boeblingen GmbH · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
53d
Days
Class 2
Risk

K081937 is an FDA 510(k) clearance for the PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Bw, DE). The FDA issued a Cleared decision on August 29, 2008 after a review of 53 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 Boeblingen GmbH devices

Submission Details

510(k) Number K081937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date August 29, 2008
Days to Decision 53 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
87d faster than avg
Panel avg: 140d · This submission: 53d
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 K081937.
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K081659 · Masimo Corporation · Sep 2008
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
K081870 · GE Healthcare Finland Oy · Jul 2008
FINGER PULSE OXIMETER, MODEL 9560
K081285 · Nonin Medical, Inc. · Jun 2008
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
K080255 · Nonin Medical, Inc. · May 2008