510(k) K223498 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Radius VSM and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 1, 2023 |
| Received | Nov 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Masimo Corporation Radius VSM ECG pre-connected Set, REF: 4842, 4695 Open, Classified |
MHX | None listed |
| Jul 2, 2026 | Masimo Corporation Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.