Cleared Traditional

K163453 - VitalPatch VitalConnect Platform

K163453 is an FDA 510(k) clearance for VitalPatch VitalConnect Platform, manufactured by Vitalconnect, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K163453 · Vitalconnect, Inc. · Cardiovascular device
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Nov 2017
Decision
328d
Days
Class 2
Risk

K163453 is an FDA 510(k) clearance for the VitalPatch® VitalConnect Platform. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Vitalconnect, Inc. (Campbell, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vitalconnect, Inc. devices

FDA 510(k) Submission Details - K163453

510(k) Number K163453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2016
Decision Date November 02, 2017
Days to Decision 328 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
203d slower than avg
Panel avg: 125d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K163453.
ScioCardio ECG Transmitter
K171019 · Synergen Technology Labs, LLC · May 2018
BioStamp nPoint
K173510 · Mc10, Inc. · May 2018
Patient Status Engine
K172329 · Isansys Lifecare, Ltd. · Apr 2018
FFR Link, FFR Signal Processing Module
K170204 · Boston Scientific Corporation · Mar 2017
TelePatch Cardiac Monitor
K161916 · Medicomp, Inc. · Dec 2016
SURVEYOR S4 MOBILE MONITOR
K141020 · Mortara Instrument, Inc. · Dec 2014