# K913811: Fukuda Denshi Model FCP-4101

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Dec 9, 1991 after 105 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971440: Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph (1997), 3 descendants of its own
- K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph (1998), 2 descendants of its own
- K173226: CardiMax Electrocardiograph (2018), 0 descendants of its own
- K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K913811
Methodology: https://510kreport.com/methodology