AccurECG Analysis System (v2.0)— 510(k) K252361

Name: FDA 510(k) clearance K252361
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Substantially Equivalent

Accurkardia, Inc.

FDA 510(k) clearance K252361 for AccurECG Analysis System (v2.0), Substantially Equivalent on 2025-12-22. Applicant: Accurkardia, Inc.. Device class: 2.

Clearance details

Applicant: Accurkardia, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2025-07-29
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

view all

K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06
K243252 — ZBPro Diagnostic2025-07-10

More clearances from Accurkardia, Inc.

view all

K223013 — AccurECG Analysis System2023-06-23

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.