# K142865: Nellcor Bedside SpO2 Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Mar 26, 2015 after 177 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962603 (1997). 52 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123581: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside SPO2 Patien, Covidien, Formerly Nellcor Puritan Bennett, Inc. (2013) Summary page 6.
- K120773: Nellcor Bedside SPO2 Patient Monitoring System, Covidien, LLC (2012) Summary page 6.
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw, Covidien (2014) Summary page 6.

## Most influential descendants
- K152659: V10 (2016), 2 descendants of its own
- K170497: V10 (2017), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Recalls of this device
- Jun 23, 2025 · Class II · Z-2151-2025: Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manu

## Indications for use
The Nellcor Bedside SpO2 Patient Monitoring System is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System 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, or home environments. 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. • Home environment includes any environment other than a professional healthcare facility or clinical laboratory where a device may be used.

Source page: https://510kreport.com/device/K142865
Methodology: https://510kreport.com/methodology