FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Radius VSM and Accessories
K Number: K250757
·
Decision May 29, 2025
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
85
Review Days
78
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Basic Information
- Device Name
- Radius VSM and Accessories
- K Number
- K250757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- March 12, 2025
- Decision Date
- May 29, 2025
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Masimo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K254209 | Radius VSM and Accessories | Jun 4, 2026 | Substantially Equivalent |
| K243324 | Masimo O3 Regional Oximeter | Jul 17, 2025 | Substantially Equivalent |
| K243305 | Masimo W1 | Apr 3, 2025 | Substantially Equivalent |
| K240229 | Masimo W1 | Aug 8, 2024 | Substantially Equivalent |
| K234021 | Masimo Stork | May 3, 2024 | Substantially Equivalent |
| K214115 | MightySat -OTC | Jan 31, 2024 | Substantially Equivalent |
| K223721 | Masimo Stork | Dec 15, 2023 | Substantially Equivalent |
| K232512 | Masimo W1 | Nov 17, 2023 | Substantially Equivalent |
| DEN200076 | ORi | Oct 12, 2023 | Unknown |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Sep 7, 2023 | Substantially Equivalent |