Cleared Traditional

K030535 - EKGCARD SYSTEM

K030535 is an FDA 510(k) clearance for EKGCARD SYSTEM, manufactured by Qrs Diagnostic, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K030535

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.

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 Peers - DPS Electrocardiograph

All 331
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K030535.
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
X-SCRIBE II
K022618 · Mortara Instrument, Inc. · Sep 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · Cambridge Heart, Inc. · Jul 2002