Cleared Traditional

Intra.Ox 2.0 Handheld Tissue Oximeter (K191676) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191676 · Vioptix, Inc. · General & Plastic Surgery device
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Sep 2019
Decision
84d
Days
Class 2
Risk

K191676 is an FDA 510(k) clearance for the Intra.Ox 2.0 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 September 16, 2019 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vioptix, Inc. devices

Submission Details

510(k) Number K191676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2019
Decision Date September 16, 2019
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 General & Plastic Surgery 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 26
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K191676.
MIMOSA Imager
K190334 · Mimosa Diagnostics, Inc. · Nov 2019
FORE-SIGHT ELITE Tissue Oximeter Module
K190270 · Cas Medical Systems, Inc. · Oct 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · Spectros Corporation · Sep 2019
Masimo O3 Regional Oximeter System
K182429 · Masimo Corporation · Jun 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · Nonin Medical, Inc. · May 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · Covidien, LLC · Jan 2019