# K053477: Masimo Set Rad 57 CM and M Pulse CO-Oximeters

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Mar 16, 2006 after 92 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). 5 ancestors in all.
226 later devices descend from it; 2 cite it directly.
2 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042536: Masimo Set Rad 57 Pulse CO-Oximeter, Masimo Corporation (2005) Summary page 1.
- K853990: OSM3 Hemoximeter, Radiometer America, Inc. (1985) Summary page 1.

## Most influential descendants
- 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
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own
- K110028: Masimo Radical Y Pulse CO-Oximeter (2011), 89 descendants of its own

## Indications for use
The Masimo SET® Rad-57 cm Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP 2 sensor) and carboxyhemoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 cm 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. The Masimo SET® Rad-57 m Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO2 sensor) and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 m 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.

Source page: https://510kreport.com/device/K053477
Methodology: https://510kreport.com/methodology