# K983287: Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Nov 5, 1998 after 48 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) Cardiotronics Systems, Inc., a division of Ballard Medical Products, R2® Pads™ Pacing/Defibrillation and ECG Electrode: named in the summary without a submission number

## Indications for use
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.

Source page: https://510kreport.com/device/K983287
Methodology: https://510kreport.com/methodology