Cleared Traditional

K992703 - CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800

K992703 is an FDA 510(k) clearance for CARDIOTRON EKG MULTI-PHASE INFORMATION ..., manufactured by Premier Heart, LLC. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K992703 · Premier Heart, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
222d
Days
Class 2
Risk

K992703 is an FDA 510(k) clearance for the CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Premier Heart, LLC (Washington, US). The FDA issued a Cleared decision on March 21, 2000 after a review of 222 days - an extended review 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: 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 Premier Heart, LLC devices

FDA 510(k) Submission Details - K992703

510(k) Number K992703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1999
Decision Date March 21, 2000
Days to Decision 222 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
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQK Computer, Diagnostic, Programmable

All 327
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K992703.
CARTO EP NAVIGATION SYSTEM
K000248 · Biosense Webster, Inc. · May 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · Biosense Webster, Inc. · May 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · Ep Medsystems, Inc. · Mar 2000
QMS MAPPING SYSTEM,MODEL 2000
K990058 · Cathdata, Inc. · Dec 1999
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · Biosense Webster, Inc. · Dec 1999
ENSITE 3000 SYSTEM
K992479 · Endocardial Solutions, Inc. · Dec 1999