FDA 510(k) · Masimo
K120984: MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR (Masimo Corporation)
Masimo Corporation received FDA 510(k) K120984 for MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR, with a decision date of Apr 26, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K120984 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 2, 2012 |
| Decision date | Apr 26, 2013 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
510(k) Number: K120984 _______DeviceName: - Masimo Acoustic Respiration Sensor (Adult/Pediatric) 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. Prescription Use X ADO Over-The-Counter Use ____ (Part 21 CFR 801 Subpart D) AN/R(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) -~ha. Lee -S f1011t4.25 14:13:49 7/;--4x For LS (DM3101 Sliwiff 1 ONIlof of AnesthSSI@ 09% General Hospial InfectON ControL Dental Devices 51o(k) Number1,~h
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.
- K091241 MASIMO RAINBOW SET RADICAL 7 PULSE CO-O… (Masimo)
Later records that cite K120984
- K173976 Masimo Acoustic Respiration Sensors, infant and neonate (Masimo, Sep 5, 2018, BZQ)
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 DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.