# K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software

- Pathway: 510(k) (Abbreviated)
- Applicant: Covidien
- Decided: Sep 28, 2012 after 100 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 48 ancestors in all.
45 later devices descend from it; 3 cite it directly.
1 of 94 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083325: N-600X with SPD, Oximax N-600X, Covidien (2009) Summary page 1.
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0, Covidien (2012) Summary page 1.

## Most influential descendants
- 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
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own

## Indications for use
For Covidien Nelicor Bedside Respiratory Patient Monitoring System with Respiration Rate Software: The Nellcor h Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO 2) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD Tm Alert (SPO) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The Respiration Rate parameter, when used in conjunction with the Neilcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K121806
Methodology: https://510kreport.com/methodology