# K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H

- Pathway: 510(k) (Traditional)
- Applicant: Trismed Co., Ltd.
- Decided: Nov 21, 2023 after 239 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: 8 generations back to K921669 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133622: Mac 2000 Ecg Analysis System, Wipro GE Healthcare (2014) Summary page 5.

## Indications for use
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.

Source page: https://510kreport.com/device/K230834
Methodology: https://510kreport.com/methodology