# K897063: Fukuda Denshi Model DS-3300 Etr

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Feb 1, 1990 after 43 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980728: Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System (1998), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K897063
Methodology: https://510kreport.com/methodology