Cleared Special

K100915 - INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650

K100915 is an FDA 510(k) clearance for INSPECTRA STO2 TISSUE OXYGENATION MONITOR, manufactured by Hutchinson Technology, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Special 510(k) pathway after a 29-day FDA review.

K100915 · Hutchinson Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
29d
Days
Class 2
Risk

K100915 is an FDA 510(k) clearance for the INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Hutchinson Technology, Inc. (Hutchinson, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 29 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 - K100915

510(k) Number K100915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2010
Decision Date April 30, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K100915.
CEROX, MODEL 321OF
K100875 · Or-Nim Medical , Ltd. · Jan 2011
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
K094030 · Cas Medical Systems, Inc. · Dec 2010
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc. · Dec 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
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
K091224 · Somanetics Corp. · Jul 2009
K100915 · INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
Download PDF FDA Summary Hutchinson Technology…