# K991105: Ecg Electrode (Various)

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Nov 26, 1999 after 239 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.

## Most influential descendants
- K040249: Skintact Ecg Electrode (2004), 3 descendants of its own
- K073104: Skintact and Various Other Tradenames (2007), 2 descendants of its own
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own
- K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive (2008), 0 descendants of its own

## Recalls of this device
- Jul 30, 2003 · Not classified · Z-1184-03: Separation of the sensing element from the body of the electrode.

## Indications for use
An electrical conductor applied to a patient’s skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.

Source page: https://510kreport.com/device/K991105
Methodology: https://510kreport.com/methodology