Cleared Traditional

K061960 - FORE-SIGHT CEREBRAL OXIMETER MONITOR

K061960 is the FDA 510(k) clearance for FORE-SIGHT CEREBRAL OXIMETER MONITOR by Cas Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code MUD) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K061960 · Cas Medical Systems, Inc. · Cardiovascular device
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Sep 2006
Decision
56d
Days
Class 2
Risk

K061960 is an FDA 510(k) clearance for the FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040. 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 September 5, 2006 after a review of 56 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 Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K061960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2006
Decision Date September 05, 2006
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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.