# K041954: Disposable Monitoring Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.
- Decided: Sep 15, 2004 after 57 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
Longest line of descent: 1 generation back to K832877 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832877: Pre-Gelled Dispos Electrode, Advance Tech Intl. (1983) Summary page 1.
- K911518: Bunny Electrode/Stealth Solid Gel-Snap on Foam, Lead-Lok, Inc. (1992) Summary page 1.

## Indications for use
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of either wet gel or solid hydrogel can be used for better results. These electrodes can be used for short-term or long-term use. This product is disposable and should only be used for single applications, up to 3 days.

Source page: https://510kreport.com/device/K041954
Methodology: https://510kreport.com/methodology