Cleared Traditional

K122645 - MOBILE CAREGUIDE 2100 OXIMETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122645 · Reflectance Medical, Inc. · Cardiovascular device
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Dec 2012
Decision
97d
Days
Class 2
Risk

K122645 is an FDA 510(k) clearance for the MOBILE CAREGUIDE 2100 OXIMETER. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Reflectance Medical, Inc. (Westborough, US). The FDA issued a Cleared decision on December 5, 2012 after a review of 97 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 Reflectance Medical, Inc. devices

Submission Details

510(k) Number K122645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2012
Decision Date December 05, 2012
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 73
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