# K123581: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside SPO2 Patien

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decided: May 9, 2013 after 170 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 9 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## 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

## Recalls of this device
- Jun 29, 2015 · Class II · Z-2267-2015: Potential missing segments on the display that can result in misinterpretation of data.
- Jun 29, 2015 · Class II · Z-2268-2015: Potential missing segments on the display that can result in misinterpretation of data.

## Indications for use
The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra hospital transport and home environments. The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow, through the upper airway and into the lungs. For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software; 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 (SpO2) 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 Nellcor 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. The Nellcor Bedside SpO2 Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport. Note: * Hospital use typically covers such areas as general care floors (GCFs), operating rooms, special procedure areas, intensive and critical care areas within the hospital, and in hospital type facilities. * Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. * Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

Source page: https://510kreport.com/device/K123581
Methodology: https://510kreport.com/methodology