# K220535: Cardio10

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Nov 15, 2022 after 264 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 K895520 (1990). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113306: Cardio 7, Bionet Co., Ltd. (2012) Summary page 5.
- K130322: SPM-300, Bionet Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K231160: Cardio Q50, Cardio Q70 (2023), 0 descendants of its own
- K231150: Cardio P1 (2023), 0 descendants of its own

## Indications for use
The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. Basic systems deliver 12 lead ECG’s, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. 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. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility. Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

Source page: https://510kreport.com/device/K220535
Methodology: https://510kreport.com/methodology