Cleared Traditional

K141234 - ODISSEY TISSUE OXIMETER

K141234 is an FDA 510(k) clearance for ODISSEY 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 49-day FDA review.

K141234 · Vioptix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
49d
Days
Class 2
Risk

K141234 is an FDA 510(k) clearance for the ODISSEY 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 July 1, 2014 after a review of 49 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K141234

510(k) Number K141234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date July 01, 2014
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K141234.
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