# K092838: Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Oct 15, 2009 after 30 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: 4 generations back to K000126 (2000). 4 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053269: Masimo Set Rad-8 Pulse Oximeter, Masimo Corporation (2005) Summary page 1.

## Most influential descendants
- K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors (2012), 37 descendants of its own
- K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (2015), 34 descendants of its own
- K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 (2016), 31 descendants of its own
- K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (2017), 8 descendants of its own
- K221704: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (2022), 6 descendants of its own

## Indications for use
The Masimo SET® Rad-8 Pulse Oximeter and Accessories are 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 and Accessories are 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/K092838
Methodology: https://510kreport.com/methodology