# K141542: Nellcor Portable SPO2 Patient Monitoring System ( Npspms )

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Oct 2, 2014 after 114 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: 7 generations back to K962603 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051352: Oximax NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2005) Summary page 4.
- 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 4.

## Indications for use
The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It 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, mobile, and home environments.

Source page: https://510kreport.com/device/K141542
Methodology: https://510kreport.com/methodology