# K894628: Model DS-3300 Dynascope Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Jan 8, 1990 after 168 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 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
- K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor (1997), 8 descendants of its own
- K971131: Fukuda Denshi Model DS-5100E Portable Patient Monitor (1997), 6 descendants of its own
- K032290: Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor (2003), 5 descendants of its own
- K040246: Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor (2004), 4 descendants of its own
- K081891: Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor (2008), 3 descendants of its own

Source page: https://510kreport.com/device/K894628
Methodology: https://510kreport.com/methodology