# K173226: CardiMax Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Apr 16, 2018 after 195 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: 3 generations back to K913811 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph, Fukuda Denshi USA, Inc. (1998) Summary page 4.
- K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M, Nihon Kohden America, Inc. (2007) Summary page 4.

## Indications for use
The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. The basic system delivers three (3), six (6) or twelve (12) channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate). The device is indicated in situations where an instantaneous display of ECG information or a hard copy record may be required. The device is intended to be used under the direct supervision or a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Source page: https://510kreport.com/device/K173226
Methodology: https://510kreport.com/methodology