# K964213: Trace Rite Solid Gel Ecg Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Nov 25, 1996 after 34 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051076: Zoll Stat*Padz MWP Multi-Function Electrodes (2005), 10 descendants of its own
- K110742: Onestep Adult Multi-Function Electrode (2011), 9 descendants of its own
- K120907: Zoll R Series (2012), 6 descendants of its own
- K133269: Zoll X Series (2014), 4 descendants of its own
- K141774: Zoll X Series (2014), 2 descendants of its own

Source page: https://510kreport.com/device/K964213
Methodology: https://510kreport.com/methodology