Cleared Traditional

K143436 - InvisionECG System

K143436 is an FDA 510(k) clearance for InvisionECG System, manufactured by Invisionheart, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K143436 · Invisionheart, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
171d
Days
Class 2
Risk

K143436 is an FDA 510(k) clearance for the InvisionECG System. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Invisionheart, Inc. (Nashville, US). The FDA issued a Cleared decision on May 21, 2015 after a review of 171 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K143436

510(k) Number K143436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date May 21, 2015
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Consultant

Speed TO Market, Inc.
Thomas Kroenke

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 492
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K143436.
Digital Electrocardiograph
K152384 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Dec 2015
Spaulding Electrocardiograph 2100iQ
K150564 · Spaulding Clinical Research, LLC · Aug 2015
Cardio-TriTest
K143432 · Cardio-Phoenix, Inc. · Jun 2015
QANS (Quantitative Autonomic Nervous System) Monitoring System
K142551 · Hhssystems, LLC · Apr 2015
ZywieAI Software Library
K142693 · Zywie, Inc. · Feb 2015
DIGITAL ELECTROCARDIOGRAPH
K141946 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Feb 2015
K143436 · InvisionECG System
Download PDF FDA Summary Invisionheart, Inc.