# K955416: Cardimax Model FX-2111

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Jul 15, 1996 after 231 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 K884992 (1989). 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)
- K884992: Fukuda Denshi Model FX-1201, Fukuda Denshi USA, Inc. (1989) Summary page 1.

## Indications for use
This device is intended to be used for the evaluation of the cardiovascular system. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The FX-2111 is intended to be used in a doctors office; all hospital environments; ER ICU, CCU, OR, etc.; or similar settings. This device is intended to be use on any patient; neonate, pediatric, or adult; 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/K955416
Methodology: https://510kreport.com/methodology