Cleared Traditional

K141542 - NELLCOR PORTABLE SPO2 PATIENT MONITORIN...

K141542 is an FDA 510(k) clearance for NELLCOR PORTABLE SPO2 PATIENT MONITORIN..., 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 114-day FDA review.

K141542 · Covidien, LLC · Anesthesiology device
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Oct 2014
Decision
114d
Days
Class 2
Risk

K141542 is an FDA 510(k) clearance for the NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on October 2, 2014 after a review of 114 days - within the typical 510(k) review window.

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.

View all Covidien, LLC devices

FDA 510(k) Submission Details - K141542

510(k) Number K141542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2014
Decision Date October 02, 2014
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141542.
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
Unimed Disposable and Reusable SPO2 Sensors
K142832 · Unimed Medical Supplies, Inc. · Feb 2015
EXTERNAL PULSE OXIMETER
K141024 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2015
FINGERTIP PULSE OXIMETER
K141128 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2014
FINGERTIP PULSE OXIMETER
K140682 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2014
PULSE OXIMETER
K140785 · Nonin Medical, Inc. · Jul 2014