Cleared Special

EnSite? X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite? X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

K251463 · Abbott Medical · Cardiovascular
Sep 2025
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K251463 is an FDA 510(k) clearance for the EnSite? X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite? X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on September 4, 2025, 115 days after receiving the submission on May 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K251463 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2025
Decision Date September 04, 2025
Days to Decision 115 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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