Cleared Traditional

K112820 - FORE-SIGHT ABSOLUTE TISSUE OXIMETER

K112820 is the FDA 510(k) clearance for FORE-SIGHT ABSOLUTE 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 120-day FDA review.

K112820 · Cas Medical Systems, Inc. · Cardiovascular device
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Jan 2012
Decision
120d
Days
Class 2
Risk

K112820 is an FDA 510(k) clearance for the FORE-SIGHT 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 January 26, 2012 after a review of 120 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 K112820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date January 26, 2012
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 32
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K112820.
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
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc. · Dec 2010
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009