# K981004: Sle Emg Electrodes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Laboratory Equipment, Ltd.
- Decided: Oct 21, 1998 after 217 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- 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 K870795 (1987). 7 ancestors in all.
56 later devices descend from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973529: Neuroline, Disposable Concentric Needle Electrodes, Medicotest A/S (1997) Summary page 1.
- K953887: RE-Usable Concentric Needle, Chalgren Enterprises, Inc. (1995) Summary page 1.
- K953886: RE-Usable Monopolar Needle, Chalgren Enterprises, Inc. (1995) Summary page 1.
- K932059: Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (1994) Summary page 1.
- K931966: Dantec Disposable Concentric Needle, Dantec Medical, Inc. (1994) Summary page 1.
- K912282: Disposable Monopolar Needle Electrode, Var Models, Chalgren Enterprises, Inc. (1992) Summary page 1.
- K870795: Emg Electrodes and Extension Cords, Nihon Kohden America, Inc. (1987) Summary page 2.

## Most influential descendants
- K990015: Electrode Needles (1999), 55 descendants of its own
- K022914: Rhythmlink International Subdermal Needle Electrodes (2002), 50 descendants of its own
- K112718: Nuvasive NVM5 System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own

## Indications for use
SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

Source page: https://510kreport.com/device/K981004
Methodology: https://510kreport.com/methodology