Cleared Traditional

K190270 - FORE-SIGHT ELITE Tissue Oximeter Module

K190270 is an FDA 510(k) clearance for FORE-SIGHT ELITE Tissue Oximeter Module, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MUD cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K190270 · Cas Medical Systems, Inc. · General & Plastic Surgery device
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Oct 2019
Decision
255d
Days
Class 2
Risk

K190270 is an FDA 510(k) clearance for the FORE-SIGHT ELITE Tissue Oximeter Module. 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 October 21, 2019 after a review of 255 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cas Medical Systems, Inc. devices

FDA 510(k) Submission Details - K190270

510(k) Number K190270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date October 21, 2019
Days to Decision 255 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 115d · This submission: 255d
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 General & Plastic Surgery 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 K190270.
SnapshotNIR
K201976 · Kent Imaging · Nov 2020
Masimo O3 Regional Oximeter System
K201432 · Masimo Corporation · Aug 2020
MIMOSA Imager
K190334 · Mimosa Diagnostics, Inc. · Nov 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · Spectros Corporation · Sep 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · Vioptix, Inc. · Sep 2019
Masimo O3 Regional Oximeter System
K182429 · Masimo Corporation · Jun 2019