# K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jul 9, 2010 after 143 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: 12 generations back to K962603 (1997). 48 ancestors in all.
115 later devices descend from it; 8 cite it directly.
1 of 164 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter, Masimo Corporation (2009) Summary page 1.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 1.

## Most influential descendants
- K110028: Masimo Radical Y Pulse CO-Oximeter (2011), 89 descendants of its own
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own
- K112687: Connex (R) Vital Signs Monitor 6000 Series (2011), 66 descendants of its own
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own

## Indications for use
The Masimo Rainbow SET' Radical 7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are 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. In addition, the Masimo Rainbow SETrRadical 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SP0 2) and pulse rate to multi-parameter devices for the display of those devices.

Source page: https://510kreport.com/device/K100428
Methodology: https://510kreport.com/methodology