# K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Mar 15, 2012 after 251 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 47 ancestors in all.
49 later devices descend from it; 3 cite it directly.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051896: Model 750E Series Monitor, Cas Medical Systems, Inc. (2005) Summary page 1.
- K083325: N-600X with SPD, Oximax N-600X, Covidien (2009) Summary page 1.
- K012691: Monsoon Critical Care Jet Ventilator and Accessories, Acutronic Medical Systems AG (2002) Summary page 1.

## Most influential descendants
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software (2012), 45 descendants of its own
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw (2014), 40 descendants of its own
- K141518: Nellcor Bedside Respiratory Patient Monitoring System (2015), 29 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own
- K181352: Loop System (2019), 10 descendants of its own

## Indications for use
The Covidien NeIlcor Respiration Rate Software, when used in conjunction with a Neilcor pulse oximeter and a Nelicor Respiration Rate Sensor, isintended to be used for the continuous, non-invasive monitoring of respiration rate in adults in hospitals and hospital-type facilities. The NellcorTM Adult Respiratory Sensor, when used in conjunction with a Nelicor pulse oximeter and the Nelicor Respiration Rate Software, is indicated for single patient use when continuous noninvasive arterial oxygen saturation, pulse rate and respiration rate monitoring are required for adult patients weighing more than 30 kg.

Source page: https://510kreport.com/device/K111933
Methodology: https://510kreport.com/methodology