Cleared Traditional

K191870 - VV330 Continuous ECG Platform

K191870 is the FDA 510(k) clearance for VV330 Continuous ECG Platform by VivaLNK, Inc.. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K191870 · VivaLNK, Inc. · Cardiovascular device
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Jan 2020
Decision
179d
Days
Class 2
Risk

K191870 is an FDA 510(k) clearance for the VV330 Continuous ECG Platform, VivaLNK Adhesive Patch. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by VivaLNK, Inc. (Campbell, US). The FDA issued a Cleared decision on January 7, 2020 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 VivaLNK, Inc. devices

Submission Details

510(k) Number K191870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2019
Decision Date January 07, 2020
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 71
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