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510(k) K223498

Radius VSM and Accessories by Masimo Corporation — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2023
Date Received
November 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Masimo Corporation

  • K243324 — Masimo O3 Regional Oximeter (July 17, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K240229 — Masimo W1 (August 8, 2024)
  • K234021 — Masimo Stork (May 3, 2024)
  • K214115 — MightySat -OTC (January 31, 2024)
  • K223721 — Masimo Stork (December 15, 2023)
  • K232512 — Masimo W1 (November 17, 2023)
  • DEN200076 — ORi (October 12, 2023)
  • K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (September 7, 2023)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)