# K073024: Masimo Rainbow Set Rad 87 Pulse CO-Oximeter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Feb 8, 2008 after 105 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: 8 generations back to K000126 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071024: Modification to: Rainbow Adhesive CO-Oximetry Sensors, Masimo Corporation (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K061206: Acute Bone Screw, Acute Innovations, LLC (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO 2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo Rainbow SET® Rad 87 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/K073024
Methodology: https://510kreport.com/methodology