# K182887: Masimo Rad-67 Pulse CO-Oximeter and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Mar 22, 2019 after 158 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: 9 generations back to K000126 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 5.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 6.

## Indications for use
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical and non-clinical settings. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients. The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

Source page: https://510kreport.com/device/K182887
Methodology: https://510kreport.com/methodology