Cleared Traditional

AccurECG Analysis System (v2.0)

K252361 · Accurkardia, Inc. · Cardiovascular
Dec 2025
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K252361 is an FDA 510(k) clearance for the AccurECG Analysis System (v2.0), a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Accurkardia, Inc. (New York, US). The FDA issued a Cleared decision on December 22, 2025, 146 days after receiving the submission on July 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K252361 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2025
Decision Date December 22, 2025
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340