# K172068: Kenz Cardico1211

- Pathway: 510(k) (Traditional)
- Applicant: Suzuken Co., Ltd.
- Decided: Jun 1, 2018 after 329 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: 1 generation back to K870443 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870443: Kenz-Cardico 1201, Suzuken Co., Ltd. (1987) Summary page 6.

## Indications for use
The Kenz Cardico 1211 is indicated for routine ECG acquisition and ECG signal analysis. It is equipped with an auto-analysis function and is not intended to replace the physician’s reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (19 years or older age). Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block. Locations: Hospitals. Caution: US Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K172068
Methodology: https://510kreport.com/methodology