Cleared Traditional

K113811 - V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

K113811 is an FDA 510(k) clearance for V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP ..., manufactured by C.R. Bard Inc., Bard Electrophysiology Division. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K113811 · C.R. Bard Inc., Bard Electrophysiology Division · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
84d
Days
Class 2
Risk

K113811 is an FDA 510(k) clearance for the V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by C.R. Bard Inc., Bard Electrophysiology Division (Lowell, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 84 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 C.R. Bard Inc., Bard Electrophysiology Division devices

FDA 510(k) Submission Details - K113811

510(k) Number K113811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date March 16, 2012
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 295
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K113811.
ST80I STRESS TEST SYSTEM
K121638 · Philips Health Care · Jul 2012
INTELLISPACE ECG
K120855 · Philips Health Care · Jun 2012
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · Biosense Webster, Inc. · May 2012
ENSITE VELOCITY SYSTEM V.3.0
K112688 · St Jude Medical · Nov 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · Ge Healthcare · Oct 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K112007 · Biosense Webster, Inc. · Oct 2011