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
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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
Combination Product No
PCCP Authorized No
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 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 K141234.
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · Cas Medical Systems, Inc. · Apr 2015
INTRA. OX HANDHELD TISSUE OXIMETER
K133983 · Vioptix, Inc. · Sep 2014
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · Reflectance Medical, Inc. · Aug 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · Cas Medical Systems, Inc. · Apr 2014
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
K133923 · Reflectance Medical, Inc. · Apr 2014
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
K130079 · Reflectance Medical, Inc. · Jul 2013