Cleared Traditional

K094030 - FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030

K094030 is an FDA 510(k) clearance for FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATI..., 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 358-day FDA review.

K094030 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
358d
Days
Class 2
Risk

K094030 is an FDA 510(k) clearance for the FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2.... 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 December 23, 2010 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K094030

510(k) Number K094030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date December 23, 2010
Days to Decision 358 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
233d slower than avg
Panel avg: 125d · This submission: 358d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00849940 Terminated Interventional

Validation of Brain Oxygenation Monitor on Pediatric Patients

Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications

72
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Cardiac Catheterization
Study design Single group
Eligibility All sexes
Principal investigator David B MacLeod, FCRA
Sponsor Duke University
Started 2009-02-01 → Primary completion 2014-11-01
Primary outcome
Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation
Secondary outcome
Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation
View full study on ClinicalTrials.gov

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 K094030.
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · Cas Medical Systems, Inc. · Jan 2012
INPECTRA STO2 SPOT CHECK
K103613 · Hutchinson Technology, Inc. · Mar 2011
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc. · Dec 2010
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009