Cleared Traditional

K042799 - QRS-CARD CARDIOLOGY SUITE

K042799 is an FDA 510(k) clearance for QRS-CARD CARDIOLOGY SUITE, manufactured by Pulse Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K042799 · Pulse Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
14d
Days
Class 2
Risk

K042799 is an FDA 510(k) clearance for the QRS-CARD CARDIOLOGY SUITE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Pulse Biomedical, Inc. (Norristown, US). The FDA issued a Cleared decision on October 22, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042799

510(k) Number K042799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2004
Decision Date October 22, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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

Citech
ROBERT MOSENKIS

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 - DQK Computer, Diagnostic, Programmable

All 422
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K042799.
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
K042849 · Cardiobiomedical Corporation · Jan 2005
VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS
K033266 · Medical Imaging Applications, LLC · Dec 2004
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
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SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
K042002 · Ela Medical, Inc. · Oct 2004
ENSITE SYSTEM, MODEL EE3000
K042493 · Endocardial Solutions, Inc. · Oct 2004
HOLTER PLUS
K042463 · Rozinn Electronics, Inc. · Sep 2004
K042799 · QRS-CARD CARDIOLOGY SUITE
Download PDF FDA Summary Pulse Biomedical, Inc.