# K173976: Masimo Acoustic Respiration Sensors, infant and neonate

- Pathway: 510(k) (Abbreviated)
- Applicant: Masimo Corporation
- Decided: Sep 5, 2018 after 250 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 49 ancestors in all.
No later device cites it as a predicate yet.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120984: Masimo Ras-125C Acoustic Respiration Sensor, Masimo Corporation (2013) Summary page 4.

## Indications for use
The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

Source page: https://510kreport.com/device/K173976
Methodology: https://510kreport.com/methodology