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FDA 510(k)

Radius VSM and Accessories

K-Number: K254209 · 2026-06-04

ApplicantMasimo Corporation
Decision Date2026-06-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radius VSM and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K254209. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radius VSM and Accessories?

Radius VSM and Accessories is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Masimo Corporation. The 510(k) number is K254209.

When did Radius VSM and Accessories receive FDA 510(k) clearance?

Radius VSM and Accessories received FDA 510(k) clearance on 2026-06-04, under 510(k) number K254209.

Who is the listed applicant for Radius VSM and Accessories?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radius VSM and Accessories?

The FDA product code for Radius VSM and Accessories is MHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07223164Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular DiseaseCOMPLETEDNCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT07223177Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric PopulationsRECRUITING

Other records listing Masimo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260880SedLine Sedation MonitorK243324Masimo O3 Regional OximeterK250757Radius VSM and AccessoriesK243305Masimo W1K240229Masimo W1K234021Masimo Stork

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)Shanghai Draeger Medical Instrument Co., Ltd.K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)Philips Medizin Systeme Boeblingen GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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