# K771645: Electrocardiographic Cablhs & Lead Wire

- Pathway: 510(k) (Traditional)
- Applicant: Tronomed, Inc.
- Decided: Oct 18, 1977 after 50 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 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
- K132253: Removable Patient Leads Ecg Cable (2013), 1 descendant of its own
- K172591: Fixed Patient Leads ECG Cable (Model 3153) (2017), 0 descendants of its own
- K984263: Ewc:  Ecg II Cable Leadwire System (1999), 0 descendants of its own
- K982817: Ewc: Ecg Cable and Leadwire Systems (1998), 0 descendants of its own
- K954900: 3M Red Dot Ecg Lead Wires a (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K771645
Methodology: https://510kreport.com/methodology