# K955923: Medi-Trace Combination Defibrillation & Ecg Electrode for Laerdal

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Oct 24, 1996 after 301 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laerdal Heartstart® Defibrillation Electrode: named in the summary without a submission number

## Indications for use
Intended for use in defibrillation procedures. This device also allows for ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.

Source page: https://510kreport.com/device/K955923
Methodology: https://510kreport.com/methodology