# K103134: Fukuda Denshi

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Mar 11, 2011 after 137 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K897063 (1990). 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)
- K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System, Fukuda Denshi USA, Inc. (2004) Summary page 2.

## Indications for use
The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.

Source page: https://510kreport.com/device/K103134
Methodology: https://510kreport.com/methodology