FDA 510(k) · Masimo
K173976: Masimo Acoustic Respiration Sensors, infant and neonate (Masimo Corporation)
Masimo Corporation received FDA 510(k) K173976 for Masimo Acoustic Respiration Sensors, infant and neonate, with a decision date of Sep 5, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K173976 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Acoustic Respiration Sensors, infant and neonate |
| Product code | BZQ: Monitor, Breathing Frequency |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Dec 29, 2017 |
| Decision date | Sep 5, 2018 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Abbreviated |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K120984 MASIMO RAS-125C ACOUSTIC RESPIRATION SE… (Masimo)
Later records that cite K173976
- K191882 Masimo Centroid System (Masimo, Apr 22, 2020, MWI)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code BZQ is "Monitor, Breathing Frequency", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Other, sensor Other. These are heuristics, not FDA fields.