# K042536: Masimo Set Rad 57 Pulse CO-Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jan 19, 2005 after 121 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000126 (2000). 4 ancestors in all.
244 later devices descend from it; 2 cite it directly.
2 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K853990: OSM3 Hemoximeter, Radiometer America, Inc. (1985) Summary page 1.

## Most influential descendants
- K053477: Masimo Set Rad 57 CM and M Pulse CO-Oximeters (2006), 226 descendants of its own
- 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

## Recalls of this device
- Feb 2, 2006 · Not classified · Z-0661-06: Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calcula

## Indications for use
The Masimo Rainbow SET Rad 57 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 SpO₂ sensor) and carboxyhernoglobin saturation (measured by an SpCO sensor). The Masimo SET Rad 57 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/K042536
Methodology: https://510kreport.com/methodology