# K162675: Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Dec 28, 2016 after 93 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: 36 generations back to K941811 (1994). 259 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 261 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors, Philips Medizin Systeme Boeblingen GmbH (2015) Summary page 4.
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 4.

## Most influential descendants
- K232389: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (2023), 0 descendants of its own

## Indications for use
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies. The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused. The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

Source page: https://510kreport.com/device/K162675
Methodology: https://510kreport.com/methodology