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
Combination Product No
PCCP Authorized No
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 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 K133983.
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
NIRO-200NX
K143219 · Hamamatsu Photonics K.K. · Jul 2015
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · Cas Medical Systems, Inc. · Apr 2015
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · Reflectance Medical, Inc. · Aug 2014
ODISSEY TISSUE OXIMETER
K141234 · Vioptix, Inc. · Jul 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · Cas Medical Systems, Inc. · Apr 2014