# K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System

- Pathway: 510(k) (Special)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Jun 3, 2004 after 190 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: 2 generations back to K897063 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980728: Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System, Fukuda Denshi USA, Inc. (1998) Summary page 1.
- K010413: Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI, Konica Minolta Sensing, Inc. (2001) Summary page 1.

## Most influential descendants
- K103134: Fukuda Denshi (2011), 0 descendants of its own

## Indications for use
The Fukuda Denshi DS-5000 series Telemetry Monitoring System is indicated in those situations where centrally located hom cJynamic monitoring (central station monitoring) of one or more patients cardioviz,cular condition is desired and those patients are currently monitored by a Fukuda Denshi bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g. ER, ICU or clinic). It is not intended for home use. This device is intended for Prescription Use Only

Source page: https://510kreport.com/device/K033711
Methodology: https://510kreport.com/methodology