Cleared Traditional

K001305 - MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

K001305 is the FDA 510(k) clearance for MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K001305 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
64d
Days
Class 2
Risk

K001305 is an FDA 510(k) clearance for the MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Sugarland, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 64 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.

View all General Electric Medical Systems Information Techn devices

Submission Details

510(k) Number K001305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2000
Decision Date June 27, 2000
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 259
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K001305.
SYNETEC
K002817 · Ela Medical, Inc. · May 2001
ASTRONOMER+WITH SLD
K003362 · Boston Scientific Corp · Mar 2001
CATHCOR DESKTOP
K002137 · Siemens Elema AB · Oct 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · Biosense Webster, Inc. · May 2000
CARTO EP NAVIGATION SYSTEM
K000248 · Biosense Webster, Inc. · May 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · Biosense Webster, Inc. · May 2000