Cleared Traditional

K142865 - Nellcor Bedside SpO2 Patient Monitoring System (FDA 510(k) Clearance)

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

K142865 · Covidien, LLC · Anesthesiology device

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Mar 2015

Decision

177d

Days

Class 2

Risk

K142865 is an FDA 510(k) clearance for the Nellcor Bedside SpO2 Patient Monitoring System. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 177 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number	K142865 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2014
Decision Date	March 26, 2015
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

38d slower than avg

Panel avg: 139d · This submission: 177d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DQA Oximeter
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 Anesthesiology devices follow this clearance model.