Cleared Traditional

K142865 - Nellcor Bedside SpO2 Patient Monitoring System

K142865 is an FDA 510(k) clearance for Nellcor Bedside SpO2 Patient Monitoring..., manufactured by Covidien, LLC. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K142865 · Covidien, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K142865

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 140d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DQA Oximeter

All 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K142865.
Pulse Oximeter, Models PC-66A
K150093 · Shenzhen Creative Industry Co., Ltd. · Jun 2015
PULSE OXIMETER CMS50EW
K141362 · Contec Medical Systems Co.,Ltd · Apr 2015
Pulse Oximeter
K142687 · Shanghai Berry Electronic Tech Co., Ltd. · Apr 2015
Vyntus Walk
K142959 · Carefusion Germany 234 GmbH · Mar 2015
Assurance Alar / Nasal SpO2 Sensor
K143216 · Xhale, Inc. · Mar 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015