# K053269: Masimo Set Rad-8 Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Dec 21, 2005 after 28 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: 3 generations back to K000126 (2000). 3 ancestors in all.
83 later devices descend from it; 5 cite it directly.
0 of 87 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)
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 1.

## Most influential descendants
- K092838: Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8 (2009), 38 descendants of its own
- K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 (2006), 38 descendants of its own
- K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors (2012), 37 descendants of its own
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own

## Indications for use
The Masimo SET® Rad-8 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-8 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K053269
Methodology: https://510kreport.com/methodology