# K033998: Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Mar 19, 2004 after 86 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: 2 generations back to K000126 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.
- K001930: Model 8500, Hand Held Pulse Oximeter, Model 8500, Nonin Medical, Inc. (2000) Summary page 1.

## Indications for use
The Masimo SETO Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor). The Masimo SET® Rad 5v Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments..

Source page: https://510kreport.com/device/K033998
Methodology: https://510kreport.com/methodology