Cleared Special

K192322 - T-Stat 2.0 Microvascular Tissue Oximeter

K192322 is the FDA 510(k) clearance for T-Stat 2.0 Microvascular Tissue Oximeter by Spectros Corporation. It is a Class 2 General & Plastic Surgery device (product code MUD) cleared through the Special 510(k) pathway after a 27-day FDA review.

K192322 · Spectros Corporation · General & Plastic Surgery device
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Sep 2019
Decision
27d
Days
Class 2
Risk

K192322 is an FDA 510(k) clearance for the T-Stat 2.0 Microvascular Tissue Oximeter. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Spectros Corporation (Campbell, US). The FDA issued a Cleared decision on September 23, 2019 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery 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 Spectros Corporation devices

Submission Details

510(k) Number K192322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2019
Decision Date September 23, 2019
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 31
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K192322.
Masimo O3 Regional Oximeter System
K201432 · Masimo Corporation · Aug 2020
MIMOSA Imager
K190334 · Mimosa Diagnostics, Inc. · Nov 2019
FORE-SIGHT ELITE Tissue Oximeter Module
K190270 · Cas Medical Systems, Inc. · Oct 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · Vioptix, Inc. · Sep 2019
Masimo O3 Regional Oximeter System
K182429 · Masimo Corporation · Jun 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · Nonin Medical, Inc. · May 2019