Cleared Traditional

K212061 - EnSite X EP System

K212061 is an FDA 510(k) clearance for EnSite X EP System, manufactured by Abbott. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K212061 · Abbott · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
113d
Days
Class 2
Risk

K212061 is an FDA 510(k) clearance for the EnSite X EP System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Abbott (St. Paul, US). The FDA issued a Cleared decision on October 22, 2021 after a review of 113 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 Abbott devices

FDA 510(k) Submission Details - K212061

510(k) Number K212061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2021
Decision Date October 22, 2021
Days to Decision 113 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 268
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K212061.
Vektor Computational ECG Mapping System (vMap)
K211546 · Vektor Medical, Inc. · Nov 2021
IM007
K210543 · Implicity, Inc. · Nov 2021
CARTO 3 EP Navigation System Version 7.2
K213264 · Biosense Webster, Inc. · Oct 2021
AVVIGO Guidance System II
K212490 · Boston Scientific Corporation · Oct 2021
Ablamap Software
K203084 · Ablacon, Inc. · Aug 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · Acutus Medical, Inc. · Aug 2021