# K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Feb 19, 2004 after 128 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: 2 generations back to K000126 (2000). 2 ancestors in all.
279 later devices descend from it; 11 cite it directly.
5 of 282 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.

## Most influential descendants
- K042536: Masimo Set Rad 57 Pulse CO-Oximeter (2005), 244 descendants of its own
- K053477: Masimo Set Rad 57 CM and M Pulse CO-Oximeters (2006), 226 descendants of its own
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter (2006), 225 descendants of its own
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter (2008), 219 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own

## Recalls of this device
- Apr 21, 2023 · Class II · Z-1984-2023: TC-I tip clip sensor may produce readings outside the accuracy specification.

## Indications for use
The Masimo SET® Rad5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 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/K033296
Methodology: https://510kreport.com/methodology