# K011818: Sterile Emg Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Sep 6, 2001 after 87 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 K850107 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850107: Concentric Needle Electrodes-Various Sizes W/Conne, Nicolet Biomedical Instruments (1985) Summary page 1.
- K912282: Disposable Monopolar Needle Electrode, Var Models, Chalgren Enterprises, Inc. (1992) Summary page 1.
- K924521: Disposable Concentric Needle Electrode, Chalgren Enterprises, Inc. (1993) Summary page 1.
- K955335: Disposable Hypodermic Monopolar Needle Recording Electrode, Chalgren Enterprises, Inc. (1996) Summary page 1.
- K982950: Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550, Chalgren Enterprises, Inc. (1999) Summary page 1.
- K912783: Disposable Monopolar Needle Electrode, Class A Ent. (1992) Summary page 1.

## Most influential descendants
- K111131: Teca (TM) Elite Disposable Monopolar Needles (2011), 0 descendants of its own

## Indications for use
Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

Source page: https://510kreport.com/device/K011818
Methodology: https://510kreport.com/methodology