# K212555: Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: May 6, 2022 after 266 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: 5 generations back to K962603 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 4.

## Indications for use
The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, 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, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.

Source page: https://510kreport.com/device/K212555
Methodology: https://510kreport.com/methodology