# K961288: Bodytrode

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Aug 8, 1996 after 126 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
Longest line of descent: 1 generation back to K833695 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833695: Adult Monitoring Elector@@Rode 9431-300, Marquette Electronics, Inc. (1984) Summary page 1.

## Indications for use
The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.

Source page: https://510kreport.com/device/K961288
Methodology: https://510kreport.com/methodology