# K091057: Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Jul 9, 2009 after 87 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.
5 later devices descend from it; 3 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)
- K082052: Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check, Masimo Corporation (2008) Summary page 1.

## Most influential descendants
- 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
- K111403: Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories (2011), 0 descendants of its own

## Indications for use
The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

Source page: https://510kreport.com/device/K091057
Methodology: https://510kreport.com/methodology