# K231150: Cardio P1

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Nov 9, 2023 after 202 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 K895520 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220535: Cardio10, Bionet Co., Ltd. (2022) Summary page 5.

## Indications for use
The Cardio P1 Analysis System is intended to acquire, analyze, display, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information. Sending and receiving ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K231150
Methodology: https://510kreport.com/methodology