# K970585: Fukuda Denshi Dynascope Model DS-5800 Central Station Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Sep 9, 1997 after 207 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 K894628 (1990). 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)
- K894628: Model DS-3300 Dynascope Patient Monitor, Fukuda Denshi USA, Inc. (1990) Summary page 2.

## Indications for use
Use of the DS-5800N is indicated in those situations where centrally located secondary hemodynamic monitoring is desired of patients that are currently primarily monitored at bedside by a Fukuda Denshi DS-5000 series bedside monitor. The DS-5800N is indicated where information from the DS-5000 series bedside monitor would include any or all of the following parameters: ECG, respiration, invasive and/or non-invasive blood pressures, temperature, pulse oximetry or cardiac output. Use of this device is indicated only in a medically supervised healthcare environment. It is not intended for home use.

Source page: https://510kreport.com/device/K970585
Methodology: https://510kreport.com/methodology