# K990015: Electrode Needles

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: May 27, 1999 after 143 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: 2 generations back to K870795 (1987). 17 ancestors in all.
55 later devices descend from it; 5 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981004: Sle Emg Electrodes and Accessories, Specialized Laboratory Equipment, Ltd. (1998) Summary page 1.
- K973529: Neuroline, Disposable Concentric Needle Electrodes, Medicotest A/S (1997) Summary page 1.
- K961013: Disposable Needle Electrode, Medelec Intl. Corp. (1996) Summary page 1.
- K960591: RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP, Chalgren Enterprises, Inc. (1996) Summary page 1.
- K955335: Disposable Hypodermic Monopolar Needle Recording Electrode, Chalgren Enterprises, Inc. (1996) 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.
- K933806: Monopolar Emg Needle Electrode, Cadwell Laboratories, Inc. (1994) Summary page 1.
- K933796: Eeg Needle Electrode, Cadwell Laboratories, Inc. (1994) Summary page 1.
- K912283: Detachable, Disposable Monopolar Needle Electrode, Chalgren Enterprises, Inc. (1992) Summary page 1.
- K912282: Disposable Monopolar Needle Electrode, Var Models, Chalgren Enterprises, Inc. (1992) Summary page 1.
- K901280: Disposible Eeg Needle Electrodes, Medicotest, Inc. (1990) Summary page 1.
- K900098: Monopolar Needle Electrode, Oculinum, Inc. (1990) Summary page 1.
- K850107: Concentric Needle Electrodes-Various Sizes W/Conne, Nicolet Biomedical Instruments (1985) Summary page 1.

## Most influential descendants
- 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
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own

## Indications for use
Technomed Europe diagnostic needie electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment. The intended use of the Technomed devices are consistent with Code of Federal Regulations title 21,volume 8 part 882.1350.

Source page: https://510kreport.com/device/K990015
Methodology: https://510kreport.com/methodology