# K120984: Masimo Ras-125C Acoustic Respiration Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Apr 26, 2013 after 389 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: 12 generations back to K962603 (1997). 48 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter, Masimo Corporation (2009) Summary page 1.

## Most influential descendants
- K243183: RTMsense Respiratory Monitoring System (2025), 0 descendants of its own
- K173976: Masimo Acoustic Respiration Sensors, infant and neonate (2018), 0 descendants of its own

## Indications for use
The Rainbow® Acoustic Monitoring~h sensors and cables are indicated for continuous, noninvasive monitoring of respiratory rate (RRaTm). The RAS-l125 is indicated for adult patients in hospitals, hospital-type facilities, mobile and home environments. The RAS- 125c is indicated for adult and pediatric patients in hospitals, hospital-type facilities, mobile and home environments.

Source page: https://510kreport.com/device/K120984
Methodology: https://510kreport.com/methodology