Cleared Special

K091224 - OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S

K091224 is an FDA 510(k) clearance for OXYALERT NIRSENSORS, manufactured by Somanetics Corp.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Special 510(k) pathway after a 73-day FDA review.

K091224 · Somanetics Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
73d
Days
Class 2
Risk

K091224 is an FDA 510(k) clearance for the OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Somanetics Corp. (Troy, US). The FDA issued a Cleared decision on July 9, 2009 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K091224

510(k) Number K091224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date July 09, 2009
Days to Decision 73 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K091224.
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
K100915 · Hutchinson Technology, Inc. · Apr 2010
CEROX MODEL 3210
K093923 · Or-Nim Medical , Ltd. · Jan 2010
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
K082327 · Somanetics Corp. · Apr 2009
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · Spectros Corporation · Jul 2008
K091224 · OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
Download PDF FDA Summary Somanetics Corp.