# K791006: Smart Bilectrodes

- Pathway: 510(k) (Traditional)
- Applicant: Electronics For Medicine, Inc.
- Decided: Jun 11, 1979 after 11 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- 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
- K962115: Cambridge Heart HI-Res Ecg Electrode (1996), 2 descendants of its own
- K013615: Micro-Induction 1000 System (2002), 1 descendant of its own
- K090249: Modification to: Micro-Induction 1000 System (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K791006
Methodology: https://510kreport.com/methodology