Cleared Traditional

K221213 - EnSite X EP System

K221213 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.

K221213 · Abbott · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
113d
Days
Class 2
Risk

K221213 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 August 18, 2022 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 - K221213

510(k) Number K221213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2022
Decision Date August 18, 2022
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 K221213.
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