Cleared Traditional

NorthStar? Mapping System

K252164 · Imricor Medical Systems · Cardiovascular
Jan 2026
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K252164 is an FDA 510(k) clearance for the NorthStar? Mapping System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Imricor Medical Systems (Burnsville, US). The FDA issued a Cleared decision on January 28, 2026, 202 days after receiving the submission on July 10, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252164 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2025
Decision Date January 28, 2026
Days to Decision 202 days
Submission Type Traditional
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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