Cleared Traditional

K012759 - INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325

K012759 is an FDA 510(k) clearance for INSPECTRA TISSUE SPECTROMETER SYSTEM (I..., 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 153-day FDA review.

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

FDA 510(k) Submission Details - K012759

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.

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.