Cleared Traditional

K030419 - VITERION 100 TELEHEALTH MONITOR

K030419 is an FDA 510(k) clearance for VITERION 100 TELEHEALTH MONITOR, manufactured by Viterion Telehealthcare, LLC. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K030419 · Viterion Telehealthcare, LLC · Cardiovascular device
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Nov 2003
Decision
269d
Days
Class 2
Risk

K030419 is an FDA 510(k) clearance for the VITERION 100 TELEHEALTH MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Viterion Telehealthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on November 6, 2003 after a review of 269 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 Viterion Telehealthcare, LLC devices

FDA 510(k) Submission Details - K030419

510(k) Number K030419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date November 06, 2003
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 154
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K030419.
TRIO MONITOR MODEL 0998-00-0600
K032338 · Datascope Corp. · Feb 2004
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · Philips Medical Systems · Dec 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · Nihon Kohden America, Inc. · Sep 2003
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc. · Mar 2003
UNITY NETWORK ID
K021454 · General Electric Medical Systems Information Techn · Oct 2002