FDA 510(k) · Masimo
K254209: Radius VSM and Accessories (Masimo Corporation)
Masimo Corporation received FDA 510(k) K254209 for Radius VSM and Accessories, with a decision date of Jun 4, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254209 |
|---|---|
| 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 | Dec 29, 2025 |
| Decision date | Jun 4, 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
We could not extract the indications for this record because FDA's summary PDF was not available at the usual address. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the 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 Unknown. These are heuristics, not FDA fields.