# K110028: Masimo Radical Y Pulse CO-Oximeter

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Mar 17, 2011 after 71 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: 13 generations back to K962603 (1997). 49 ancestors in all.
89 later devices descend from it; 8 cite it directly.
1 of 139 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 1.

## Most influential descendants
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own

## Indications for use
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 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 Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate to multi-parameter devices for the display of those devices.

Source page: https://510kreport.com/device/K110028
Methodology: https://510kreport.com/methodology