# K252361: AccurECG Analysis System (v2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Accurkardia, Inc.
- Decided: Dec 22, 2025 after 146 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003621 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223013: AccurECG Analysis System, Accurkardia, Inc. (2023) Summary page 6.

## Indications for use
The AccurECG@ Analysis System v2.0 is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing. The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG@ Analysis System v2.0 is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads). The AccurECG@ Analysis System v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors. The AccurECG@ Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion. The AccurECG@ Analysis System v2.0 does not interface with data management systems or hardware and is device independent.

Source page: https://510kreport.com/device/K252361
Methodology: https://510kreport.com/methodology