# K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 4, 2014 after 361 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: 11 generations back to K962603 (1997). 49 ancestors in all.
40 later devices descend from it; 5 cite it directly.
1 of 90 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software, Covidien (2012) Summary page 1.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own

## Indications for use
The Nellcor ) 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 (Sp02) and pulse rate of adult, pediatric, and neonatal patients during both no motion and motion conditions, 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"' Alert (SPD) 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 Nelicorm Bedside Respiratory Patient Monitoring System and NellcorTM Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients who are well perfused during no motion conditions, in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K130320
Methodology: https://510kreport.com/methodology