# K980728: Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Jun 19, 1998 after 114 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 1 generation back to K897063 (1990). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897063: Fukuda Denshi Model DS-3300 Etr, Fukuda Denshi USA, Inc. (1990) Summary page 1.
- K963057: Fukuda Denshi Model LX-3240 Ecg & Respiratory Transmitter, Fukuda Denshi USA, Inc. (1997) Summary page 1.
- K914092: BSM-2100A Configured Patient Monitor, Nihon Kohden America, Inc. (1992) Summary page 1.

## Most influential descendants
- K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System (2004), 1 descendant of its own
- 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 hemodynamic monitoring (central station monitoring) of one or more patients’s cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi DS-5000 series 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). Itis not intended for home use

Source page: https://510kreport.com/device/K980728
Methodology: https://510kreport.com/methodology