Cleared Traditional

K260676 - Radius VSM and Accessories

K260676 is an FDA 510(k) clearance for Radius VSM and Accessories, manufactured by Masimo Corporation. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K260676 · Masimo Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
226d
Days
Class 2
Risk

K260676 is an FDA 510(k) clearance for the Radius VSM and Accessories. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 14, 2026 after a review of 226 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260676

510(k) Number K260676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date October 14, 2026
Days to Decision 226 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 125d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 429
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K260676.
Carescape ONE
K260656 · GE Healthcare Finland Oy · Sep 2026
Carescape Canvas 1000
K260343 · GE Healthcare Finland Oy · Aug 2026
Infinity® Acute Care System (IACS) – VG8.1
K260579 · Draeger Medical Systems, Inc. · Aug 2026
Telemetry Monitor (iT30, iT50)
K251508 · Edan Instruments, Inc. · Aug 2026
Radius VSM and Accessories
K254209 · Masimo Corporation · Jun 2026
M12 Telemetry System
K252840 · Global Instrumentation, LLC · May 2026
K260676 · Radius VSM and Accessories
Download PDF FDA Summary Masimo Corporation