Cleared Traditional

K133983 - INTRA. OX HANDHELD TISSUE OXIMETER

K133983 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 259-day FDA review.

K133983 · Vioptix, Inc. · Cardiovascular device
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Sep 2014
Decision
259d
Days
Class 2
Risk

K133983 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. (Irvine, US). The FDA issued a Cleared decision on September 12, 2014 after a review of 259 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 Vioptix, Inc. devices

FDA 510(k) Submission Details - K133983

510(k) Number K133983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2013
Decision Date September 12, 2014
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 Peers - MUD Oximeter, Tissue Saturation

All 39
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K133983.
Masimo O3 Regional Oximeter System
K160526 · Masimo Corporation · Jun 2016
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
K151305 · Nonin Medical, Inc. · Aug 2015
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · Cas Medical Systems, Inc. · Apr 2015
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · Cas Medical Systems, Inc. · Apr 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K123700 · Cas Medical Systems, Inc. · Apr 2013
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012