# K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Aug 31, 1998 after 160 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913811 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971440: Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph, Fukuda Denshi USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K173226: CardiMax Electrocardiograph (2018), 0 descendants of its own
- K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (2015), 0 descendants of its own

## Indications for use
Use of this device is indicated where a physician or healthcare professional requires information about the electrical events within the myocardium using waveforms recorded from the body’s surface during depolarization and repolarization of the atrium and ventricles. The FX-4010 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. Also, can provide measurement data, R to R timing measurements with trend infotmation and interpretation of arrhythmia to the clinician. The basic EKG and recording features of this device are intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. The interpretive feature of this device is intended to be used on any patient, at least one (1) year old, where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

Source page: https://510kreport.com/device/K981066
Methodology: https://510kreport.com/methodology