Cleared Special

K001437 - ENSITE 3000 SYSTEM, MODEL EE3000

K001437 is an FDA 510(k) clearance for ENSITE 3000 SYSTEM, manufactured by Endocardial Solutions, Inc.. 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.

K001437 · Endocardial Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
30d
Days
Class 2
Risk

K001437 is an FDA 510(k) clearance for the ENSITE 3000 SYSTEM, MODEL EE3000. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Endocardial Solutions, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 7, 2000 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.

View all Endocardial Solutions, Inc. devices

FDA 510(k) Submission Details - K001437

510(k) Number K001437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2000
Decision Date June 07, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 305
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K001437.
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