Cleared Traditional

K954395 - CARTO SYSTEM

K954395 is an FDA 510(k) clearance for CARTO SYSTEM, manufactured by Biosense, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K954395 · Biosense, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
92d
Days
Class 2
Risk

K954395 is an FDA 510(k) clearance for the CARTO SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense, Ltd. (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 21, 1995 after a review of 92 days - within the typical 510(k) review window.

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 Biosense, Ltd. devices

FDA 510(k) Submission Details - K954395

510(k) Number K954395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date December 21, 1995
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 361
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K954395.
AMBULATORY (HOLTER) RECORDING SYSTEM
K950723 · Biosensor Corp. · Feb 1996
OMEGA CARES SYSTEM
K945068 · J-F Medical Systems Intl., Inc. · Jan 1996
HOLTER 6000
K950988 · Omega Medical Services, Inc. · Jan 1996
EPICARDIA
K952846 · Medicomp, Inc. · Sep 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · Hogan & Hartson · Feb 1995
ALTAIR-DISC RECORDER
K942565 · Burdick Corp. · Dec 1994