Cleared Traditional

EKGCARD SYSTEM (K030535) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030535 · Qrs Diagnostic, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
111d
Days
Class 2
Risk

K030535 is an FDA 510(k) clearance for the EKGCARD SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 111 days - within the typical 510(k) review window.

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.

View all Qrs Diagnostic, LLC devices

Submission Details

510(k) Number K030535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date June 11, 2003
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Peers - DPS Electrocardiograph

All 134
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K030535.
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PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
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K020708 · Philips Medical Systems, Inc. · Apr 2002
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K002473 · Nihon Kohden America, Inc. · Nov 2000