Cleared Traditional

K241728 - Vios Monitoring System(TM) Model 2050 (FDA 510(k) Clearance)

Also includes:
Vios Central Station Monitor/Vios Central Server Software 2050

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241728 · Murata Vios, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jan 2025
Decision
223d
Days
Class 2
Risk

K241728 is an FDA 510(k) clearance for the Vios Monitoring System(TM) Model 2050. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Murata Vios, Inc. (Woodbury, US). The FDA issued a Cleared decision on January 23, 2025 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

View all Murata Vios, Inc. devices

Submission Details

510(k) Number K241728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2024
Decision Date January 23, 2025
Days to Decision 223 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 125d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 1209
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