Cleared Traditional

K180003 - FORE-SIGHT ELITE Module Tissue Oximeter

K180003 is the FDA 510(k) clearance for FORE-SIGHT ELITE Module Tissue Oximeter by Cas Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code MUD) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K180003 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
128d
Days
Class 2
Risk

K180003 is an FDA 510(k) clearance for the FORE-SIGHT ELITE Module 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 May 10, 2018 after a review of 128 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

Submission Details

510(k) Number K180003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date May 10, 2018
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K180003.
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · Covidien, LLC · Jan 2019
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
Clarifi Imaging System
K181623 · Modulated Imaging, Inc. · Jul 2018
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017
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