Cleared Traditional

K103613 - INPECTRA STO2 SPOT CHECK

K103613 is an FDA 510(k) clearance for INPECTRA STO2 SPOT CHECK, manufactured by Hutchinson Technology, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K103613 · Hutchinson Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
83d
Days
Class 2
Risk

K103613 is an FDA 510(k) clearance for the INPECTRA STO2 SPOT CHECK. 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 March 2, 2011 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hutchinson Technology, Inc. devices

FDA 510(k) Submission Details - K103613

510(k) Number K103613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2010
Decision Date March 02, 2011
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 39
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K103613.
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K123700 · Cas Medical Systems, Inc. · Apr 2013
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · Cas Medical Systems, Inc. · Jan 2012
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
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009