Cleared Traditional

INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 (K012759) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012759 · Hutchinson Technology, Inc. · Cardiovascular device
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Jan 2002
Decision
153d
Days
Class 2
Risk

K012759 is an FDA 510(k) clearance for the INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325. 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 January 17, 2002 after a review of 153 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.

View all Hutchinson Technology, Inc. devices

Submission Details

510(k) Number K012759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2001
Decision Date January 17, 2002
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
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.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 73
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