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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 428
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K033211.
HOLTER PLUS
K042463 · Rozinn Electronics, Inc. · Sep 2004
ENDO PAT 2000
K032519 · Itamar Medical · Nov 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · Ge Medical Systems Information Technologies · Oct 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · Ge Medical Systems Information Technologies · Oct 2003
GALIX WINTER
K030145 · Galix Biomedical Instrumentation, Inc. · Sep 2003
INFINITY MEGACARE
K031970 · Siemens Medical Solutions USA, Inc. · Sep 2003
K033211 · ENSITE SYSTEM
Download PDF FDA Summary Endocardial Solutions…