Cleared Traditional

K042657 - VIOPTIX ODISSEY TISSUE OXIMETER TISSUE ...

K042657 is an FDA 510(k) clearance for VIOPTIX ODISSEY TISSUE OXIMETER TISSUE ..., manufactured by Vioptix, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K042657 · Vioptix, Inc. · Cardiovascular device
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Jan 2005
Decision
104d
Days
Class 2
Risk

K042657 is an FDA 510(k) clearance for the VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Vioptix, Inc. (Irvine, US). The FDA issued a Cleared decision on January 10, 2005 after a review of 104 days - within the typical 510(k) review window.

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 Vioptix, Inc. devices

FDA 510(k) Submission Details - K042657

510(k) Number K042657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2004
Decision Date January 10, 2005
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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.