Cleared Special

K033211 - ENSITE SYSTEM

K033211 is an FDA 510(k) clearance for ENSITE 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 27-day FDA review.

K033211 · Endocardial Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
27d
Days
Class 2
Risk

K033211 is an FDA 510(k) clearance for the ENSITE SYSTEM. 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 October 30, 2003 after a review of 27 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 - K033211

510(k) Number K033211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date October 30, 2003
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 K033211.
MODIFICATION TO: RADIANALYZER, MODEL 12711
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MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · Ge Medical Systems Information Technologies · Oct 2003
INFINITY MEGACARE
K031970 · Siemens Medical Solutions USA, Inc. · Sep 2003
PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
K032038 · Quinton, Inc. · Sep 2003