Cleared Traditional

K163472 - Intra.Ox Handheld Tissue Oximeter

K163472 is an FDA 510(k) clearance for Intra.Ox Handheld Tissue Oximeter, 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 339-day FDA review.

K163472 · Vioptix, Inc. · Cardiovascular device
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Nov 2017
Decision
339d
Days
Class 2
Risk

K163472 is an FDA 510(k) clearance for the Intra.Ox Handheld Tissue Oximeter. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K163472

510(k) Number K163472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date November 16, 2017
Days to Decision 339 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 125d · This submission: 339d
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.

Regulatory Consultant

ViOptix, Inc.
Mark Lonsinger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K163472.
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
Clarifi Imaging System
K181623 · Modulated Imaging, Inc. · Jul 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · Cas Medical Systems, Inc. · May 2018
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017
Kent Camera
K163070 · Kent Imaging, Inc. · May 2017
Ox-Imager CS
K153426 · Modulated Imaging, Inc. · Dec 2016