Cleared Traditional

K141518 - Nellcor Bedside Respiratory Patient Mon...

K141518 is an FDA 510(k) clearance for Nellcor Bedside Respiratory Patient Mon..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K141518 · Covidien · Anesthesiology device
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Mar 2015
Decision
269d
Days
Class 2
Risk

K141518 is an FDA 510(k) clearance for the Nellcor Bedside Respiratory Patient Monitoring System. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on March 5, 2015 after a review of 269 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.

View all Covidien devices

FDA 510(k) Submission Details - K141518

510(k) Number K141518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2014
Decision Date March 05, 2015
Days to Decision 269 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
129d slower than avg
Panel avg: 140d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01804062 Completed Observational Industry-sponsored

Respiration Rate V2.0 in Healthy Volunteers

Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

30
Patients (actual)
1
Site
Condition studied Focus of the Study is Measuring Respiratory Rate
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Scott D Kelley, MD
Sponsor Medtronic - MITG (industry)
Started 2013-02-01 → Primary completion 2013-02-01
Primary outcome
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Secondary outcome
ME +/- 1 Breath Per Minute, Max-N Sensor
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141518.
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · Masimo Corporation · Oct 2015
Fingertip Pulse Oximeter
K151206 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2015
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · Covidien, LLC · Mar 2015
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
EXTERNAL PULSE OXIMETER
K141024 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2015
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · Covidien, LLC · Oct 2014