Cleared Traditional

K143675 - FORE-SIGHT Elite Absolute Tissue Oximeter

K143675 is an FDA 510(k) clearance for FORE-SIGHT Elite Absolute Tissue Oximeter, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K143675 · Cas Medical Systems, Inc. · Cardiovascular device
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Apr 2015
Decision
107d
Days
Class 2
Risk

K143675 is an FDA 510(k) clearance for the FORE-SIGHT Elite Absolute Tissue Oximeter. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on April 10, 2015 after a review of 107 days - within the typical 510(k) review window.

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 Cas Medical Systems, Inc. devices

FDA 510(k) Submission Details - K143675

510(k) Number K143675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date April 10, 2015
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 58
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K143675.
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
NIRO-200NX
K143219 · Hamamatsu Photonics K.K. · Jul 2015
INTRA. OX HANDHELD TISSUE OXIMETER
K133983 · Vioptix, Inc. · Sep 2014
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · Reflectance Medical, Inc. · Aug 2014
ODISSEY TISSUE OXIMETER
K141234 · Vioptix, Inc. · Jul 2014