# K111403: Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Dec 30, 2011 after 225 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: 10 generations back to K000126 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100403: Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model  Pronto-7, Masimo Corporation (2010) Summary page 1.

## Indications for use
The Masimo Rainbow SET Pronto-7 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-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician offices and ambulatory surgery centers).

Source page: https://510kreport.com/device/K111403
Methodology: https://510kreport.com/methodology