# K223013: AccurECG Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Accurkardia, Inc.
- Decided: Jun 23, 2023 after 267 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: 6 generations back to K003621 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212112: Cardiologs Holter Platform, Cardiologs Technologies (2021) Summary page 5.

## Most influential descendants
- K252361: AccurECG Analysis System (v2.0) (2025), 0 descendants of its own

## Indications for use
The AccurECG Analysis System 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 is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads). The AccurECG Analysis System 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 does not interface with data management systems or hardware and is device independent.

Source page: https://510kreport.com/device/K223013
Methodology: https://510kreport.com/methodology