# K863116: Cardiofax Ecg-6551 (Electrocardiogrph)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Sep 17, 1986 after 34 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 1 cites it directly.
0 of 24 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
- K982470: Ecg Electrodes Apron (1998), 22 descendants of its own
- K043361: Accuheart Electrode Belt (2005), 21 descendants of its own
- K063044: Cardiobelt Electrode Belt (2007), 18 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own

Source page: https://510kreport.com/device/K863116
Methodology: https://510kreport.com/methodology