# K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang Co.
- Decided: Oct 26, 1999 after 463 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.
13 later devices descend from it; 6 cite it directly.
0 of 14 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) Skintact AG Electrodes: named in the summary without a submission number

## Most influential descendants
- K023503: Skintact Ecg Electrode (2002), 8 descendants of its own
- K023920: Skintact (2003), 5 descendants of its own
- K030509: Skintact Ecg Tab Electrode (2003), 4 descendants of its own
- K073104: Skintact and Various Other Tradenames (2007), 2 descendants of its own
- K020003: Electrocardiograph (Ecg) Electrode, Non-Sterile (2002), 2 descendants of its own

## Indications for use
Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recordings. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K982521
Methodology: https://510kreport.com/methodology