# K960968: Medi-Trace 200, Medi-Trace 200-30

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Oct 28, 1996 after 231 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
No predicates in its family tree.
31 later devices descend from it; 3 cite it directly.
0 of 32 devices 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) Medi-Trace® 500 Electrodes: named in the summary without a submission number

## Most influential descendants
- K043361: Accuheart Electrode Belt (2005), 21 descendants of its own
- K063044: Cardiobelt Electrode Belt (2007), 18 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own

## Indications for use
Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.

Source page: https://510kreport.com/device/K960968
Methodology: https://510kreport.com/methodology