# K100403: Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model  Pronto-7

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jun 23, 2010 after 127 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K000126 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091057: Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories, Masimo Corporation (2009) Summary page 1.

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

## Recalls of this device
- Dec 23, 2010 · Not classified · Z-1387-2011: Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. A

## 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 (SP02), pulse rate, and total hemoglobin concentration (SpHlb). 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. blood donation facilities, and ambulatory surgery centers).

Source page: https://510kreport.com/device/K100403
Methodology: https://510kreport.com/methodology