# K020084: Fukuda Denshi Dynascope Model DS-5700

- Pathway: 510(k) (Special)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Feb 6, 2002 after 27 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 K000746 (2000). 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)
- K000746: Fukuda Denshi Dynascope, Model DS-5800NX, Fukuda Denshi USA, Inc. (2000) Summary page 2.
- (no number) Fukuda Denshi model DS-5300NXMB: named in the summary without a submission number

## Indications for use
Use of the DS-5700 is indicated in those situations where centrally located hemodynamic monitoring of one or more patient’s cardiovascular condition is desired and those patients are currently monitored at bedside by a Fukuda Denshi DS-5000 series bedside monitor. Use of this device is indicated only in a medically supervised healthcare environment. It is not for home use.

Source page: https://510kreport.com/device/K020084
Methodology: https://510kreport.com/methodology