Cleared Special

K081233 - T-STAT 303 ISCHEMIA MONITORING SYSTEM

K081233 is an FDA 510(k) clearance for T-STAT 303 ISCHEMIA MONITORING SYSTEM, manufactured by Spectros Corporation. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Special 510(k) pathway after a 88-day FDA review.

K081233 · Spectros Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
88d
Days
Class 2
Risk

K081233 is an FDA 510(k) clearance for the T-STAT 303 ISCHEMIA MONITORING SYSTEM. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Spectros Corporation (Highlands Ranch, US). The FDA issued a Cleared decision on July 28, 2008 after a review of 88 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 - K081233

510(k) Number K081233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date July 28, 2008
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K081233.
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
K091224 · Somanetics Corp. · Jul 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
K082327 · Somanetics Corp. · Apr 2009
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · Somanetics Corp. · May 2008
PACIFICA
K073407 · Or-Nim Medical , Ltd. · Feb 2008
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
K073656 · Hypermed, Inc. · Jan 2008
K081233 · T-STAT 303 ISCHEMIA MONITORING SYSTEM
Download PDF FDA Summary Spectros Corporation