# K955882: Medi-Trace Combination Defibrillation & Ecg Electrode for Hewlett Packard Defibrillators

- 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: 2 (2 Class I)
- 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.
1 of 1 device in its family (counting itself) has 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) Hewlett® Packard M1749A Multifunction Adult Electrode: named in the summary without a submission number

## Recalls of this device
- Sep 18, 2014 · Class I · Z-0046-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Sep 18, 2014 · Class I · Z-0047-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

## Indications for use
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults. Not for use on children or infants.

Source page: https://510kreport.com/device/K955882
Methodology: https://510kreport.com/methodology