Cleared Traditional

COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 (K111933) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K111933 · Covidien · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
251d
Days
Class 2
Risk

K111933 is an FDA 510(k) clearance for the COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on March 15, 2012 after a review of 251 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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

Submission Details

510(k) Number K111933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date March 15, 2012
Days to Decision 251 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
111d slower than avg
Panel avg: 140d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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
NCT01294514 Completed Observational Industry-sponsored

Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

Novel Cardio-Respiratory Parameter in Healthy Volunteers

27
Patients (actual)
1
Site
Condition studied No Conditions; Focus is Respiratory Rate
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Scott Kelley, MD
Sponsor Medtronic - MITG (industry)
Started 2011-02-01 → Primary completion 2011-02-01 → Completed 2012-03-01
Primary outcome
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
Secondary outcome
The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
View full study on ClinicalTrials.gov

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 34
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K111933.
Masimo Acoustic Respiration Sensors, infant and neonate
K173976 · Masimo Corporation · Sep 2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
K180079 · Hill-Rom, Inc. · May 2018
EarlySense Bed Sensing Unit
K171836 · Earlysense, Ltd. · Jan 2018
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995