# K102767: Cardio XP

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Jun 3, 2011 after 252 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: 4 generations back to K895520 (1990). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072449: CP100 & 200 12-Lead Resting Electrocardiographs, Welch Allyn, Inc. (2007) Summary page 1.

## Most influential descendants
- K113306: Cardio 7 (2012), 3 descendants of its own
- K220535: Cardio10 (2022), 2 descendants of its own
- K231160: Cardio Q50, Cardio Q70 (2023), 0 descendants of its own
- K231150: Cardio P1 (2023), 0 descendants of its own

## Indications for use
The CardioXP electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Source page: https://510kreport.com/device/K102767
Methodology: https://510kreport.com/methodology