Cleared Traditional

K990058 - QMS MAPPING SYSTEM,MODEL 2000

K990058 is an FDA 510(k) clearance for QMS MAPPING SYSTEM, manufactured by Cathdata, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K990058 · Cathdata, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
342d
Days
Class 2
Risk

K990058 is an FDA 510(k) clearance for the QMS MAPPING SYSTEM,MODEL 2000. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Cathdata, Inc. (Stamford, US). The FDA issued a Cleared decision on December 15, 1999 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cathdata, Inc. devices

FDA 510(k) Submission Details - K990058

510(k) Number K990058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1999
Decision Date December 15, 1999
Days to Decision 342 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
217d slower than avg
Panel avg: 125d · This submission: 342d
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 K990058.
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · Biosense Webster, Inc. · May 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · Ep Medsystems, Inc. · Mar 2000
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · Premier Heart, LLC · Mar 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · Biosense Webster, Inc. · Dec 1999
ENSITE 3000 SYSTEM
K992479 · Endocardial Solutions, Inc. · Dec 1999
MAC-LAB SYSTEM
K992948 · General Electric Medical Systems Information Techn · Nov 1999