FDA 510(k) · Masimo
K260676: Radius VSM and Accessories (Masimo Corporation)
Masimo Corporation received FDA 510(k) K260676 for Radius VSM and Accessories, with a decision date of Oct 14, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K260676 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Radius VSM and Accessories |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Mar 2, 2026 |
| Decision date | Oct 14, 2026 |
| 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
for Radius VSM Accessories is provided below: Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact. Radius VSM Blood Pressure Cuffs are accessories intended to be used with a non-invasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions. The Masimo RD smartSET with PPG AFib disposable sensors are intended to support SpO2 monitoring and enable the PPG AFib feature on compatible devices with Masimo SET Technology. The Masimo RD smartSET with PPG AFib sensors are indicated for the monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for use with adult patients during both no motion and motion conditions, and for adult patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. 3
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.
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 MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Other. These are heuristics, not FDA fields.