# K030073: Vermed A10021 Resting Ekg Tab Electrode

- Pathway: 510(k) (Special)
- Applicant: Vermont Medical, Inc.
- Decided: Mar 28, 2003 after 79 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures. This electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.

Source page: https://510kreport.com/device/K030073
Methodology: https://510kreport.com/methodology
