# K101024: Kenz CARDY302 Max

- Pathway: 510(k) (Traditional)
- Applicant: Suzuken Co., Ltd.
- Decided: Jan 6, 2011 after 268 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001317 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050731: Seer Light Extend Compact Digital Holter System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Indications for use
The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card. The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility. The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data. The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.

Source page: https://510kreport.com/device/K101024
Methodology: https://510kreport.com/methodology