Cleared Traditional

K252013 - EnSite X EP System

K252013 is the FDA 510(k) clearance for EnSite X EP System by Abbott Medical. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K252013 · Abbott Medical · Cardiovascular device
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Sep 2025
Decision
90d
Days
Class 2
Risk

K252013 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 Medical (St. Paul, US). The FDA issued a Cleared decision on September 25, 2025 after a review of 90 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 Medical devices

Submission Details

510(k) Number K252013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2025
Decision Date September 25, 2025
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 246
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K252013.
CoroFlow Cardiovascular System
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