Cleared Traditional

K040684 - T-STAT MICROVASCULAR TISSUE OXIMETER

K040684 is the FDA 510(k) clearance for T-STAT MICROVASCULAR TISSUE OXIMETER by Spectros Corporation. It is a Class 2 Cardiovascular device (product code MUD) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K040684 · Spectros Corporation · Cardiovascular device
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Nov 2004
Decision
234d
Days
Class 2
Risk

K040684 is an FDA 510(k) clearance for the T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Spectros Corporation (Portola Valley, US). The FDA issued a Cleared decision on November 5, 2004 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K040684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date November 05, 2004
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Cardiovascular devices follow this clearance model.