# K980410: Sle Electrodes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Laboratory Equipment, Ltd.
- Decided: Oct 22, 1998 after 261 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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 K931430 (1993). 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)
- K931430: Cutaneous Electrode, Medicotest, Inc. (1993) Summary page 1.
- K933801: Electrode, Cutaneous, Cadwell Laboratories, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K760213: Lenses, Contact, Polymethyl Methacrylate, Progressive Affiliated Labs, Inc. (1976). Our OCR of the scanned summary read K760213, FDA’s number for Lenses, Contact, Polymethyl Methacrylate (Progressive Affiliated Labs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Electrode, PNS, NDM Corp.”. Kept off the family tree. Summary page 1.

## Indications for use
SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological gignals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.

Source page: https://510kreport.com/device/K980410
Methodology: https://510kreport.com/methodology