# K063140: Rainbow Adhesive CO-Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Dec 29, 2006 after 74 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: 6 generations back to K000126 (2000). 8 ancestors in all.
44 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter, Masimo Corporation (2006) Summary page 1.
- (no number) Rainbow DCI-DC Reusable CO-Oximetry Sensor: named in the summary without a submission number

## Most influential descendants
- K071024: Modification to: Rainbow Adhesive CO-Oximetry Sensors (2007), 43 descendants of its own
- K081659: Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L (2008), 41 descendants of its own
- K090165: Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20 (2009), 40 descendants of its own
- K100617: Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D (2010), 39 descendants of its own
- K111621: Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors (2011), 38 descendants of its own

## Indications for use
The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate (measured by an SP02 sensor), carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® 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 SET® Radical 7 Pulse CO-Oximeter and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.

Source page: https://510kreport.com/device/K063140
Methodology: https://510kreport.com/methodology