# K082052: Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Oct 10, 2008 after 81 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: 7 generations back to K000126 (2000). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K091057: Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories (2009), 5 descendants of its own
- K124041: NBM-200MP (2013), 1 descendant of its own
- K100403: Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model  Pronto-7 (2010), 1 descendant of its own
- K182887: Masimo Rad-67 Pulse CO-Oximeter and Accessories (2019), 0 descendants of its own
- K142209: Pulse oximeter NBM-200 (2015), 0 descendants of its own

## Indications for use
The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

Source page: https://510kreport.com/device/K082052
Methodology: https://510kreport.com/methodology