Cleared Traditional

K172586 - Vios Monitoring System Model 2050

K172586 is an FDA 510(k) clearance for Vios Monitoring System Model 2050, manufactured by Vios Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K172586 · Vios Medical, Inc. · Cardiovascular device
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Jun 2018
Decision
298d
Days
Class 2
Risk

K172586 is an FDA 510(k) clearance for the Vios Monitoring System™ Model 2050. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Vios Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 298 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

FDA 510(k) Submission Details - K172586

510(k) Number K172586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date June 22, 2018
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 193
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K172586.
Cardiac Trigger Monitor
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K202464 · Xandar Kardian, Inc. · Apr 2021
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K181165 · Connected Sensing- A Division of Philips Medical Systems · Mar 2019
Cardiac Trigger Monitor
K170828 · Ivy Biomedical Systems, Inc. · May 2017
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781 · Ivy Biomedical Systems, Inc. · May 2016
CARDIAC TRIGGER MONITOR
K110987 · Ivy Biomedical Systems, Inc. · Jul 2011