Cleared Traditional

K173107 - Vios Central Station Monitor Software, Vios Central Server Software (FDA 510(k) Clearance)

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

K173107 · Vios Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
300d
Days
Class 2
Risk

K173107 is an FDA 510(k) clearance for the Vios Central Station Monitor Software, Vios Central Server Software. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Vios Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 26, 2018 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Vios Medical, Inc. devices

Submission Details

510(k) Number K173107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date July 26, 2018
Days to Decision 300 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
175d slower than avg
Panel avg: 125d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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.