# K081659: Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-L

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Sep 9, 2008 after 89 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). 11 ancestors in all.
41 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)
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 1.
- K071024: Modification to: Rainbow Adhesive CO-Oximetry Sensors, Masimo Corporation (2007) Summary page 1.

## Most influential descendants
- 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
- K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors (2012), 37 descendants of its own
- K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (2015), 34 descendants of its own

## Indications for use
The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Adhesive Sensors 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/K081659
Methodology: https://510kreport.com/methodology