Radius VSM and Accessories
FDA 510(k) clearance K223498 · decided 2023-06-01
Clearance details
- K-number
- K223498
- Device name
- Radius VSM and Accessories
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-11-21
- Decision date
- 2023-06-01
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Radius VSM ECG pre-connected Set, REF: 4842, 4695 recall (Z-2670-2026) | Masimo Corporation | 2026-07-02 |
| Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 recall (Z-2671-2026) | Masimo Corporation | 2026-07-02 |