Cleared Special

K141185 - V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

K141185 is an FDA 510(k) clearance for V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP ..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 30-day FDA review.

K141185 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
30d
Days
Class 2
Risk

K141185 is an FDA 510(k) clearance for the V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Lowell, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141185

510(k) Number K141185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2014
Decision Date June 06, 2014
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 416
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K141185.
ECVUE MAPPING SYSTEM
K140497 · Cardioinsight Technologies, Inc. · Nov 2014
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
K133916 · Biosense Webster, Inc. · Jul 2014
ENSITE VELOCITY SYSTEM
K141050 · St Jude Medical · Jun 2014
MCKESSON CARDIOLOGY ECG MOBILE
K133534 · Mckesson Israel , Ltd. · Apr 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044 · Cardio Tek, BV · Mar 2014
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
K132782 · Biosense Webster, Inc. · Jan 2014
K141185 · V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
Download PDF FDA Summary Boston Scientific Corp