# K120773: Nellcor Bedside SPO2 Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 10, 2012 after 118 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: 7 generations back to K962603 (1997). 22 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have 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.

## Most influential descendants
- K142865: Nellcor Bedside SpO2 Patient Monitoring System (2015), 3 descendants of its own
- K152659: V10 (2016), 2 descendants of its own
- K170497: V10 (2017), 1 descendant of its own
- K131085: Central Venous Pressure System - Mespere Venus 1000 (2013), 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 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 prescription use only with neonatal, pediatric, and adult patients, 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/K120773
Methodology: https://510kreport.com/methodology