# K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Jun 3, 2016 after 238 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: 6 generations back to K870795 (1987). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle, Bionen S.A.S. (2010) Summary page 4.
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,, Technomed Europe (2013) Summary page 4.
- K050194: Axon Systems Subdermal Needle Electrodes, Axon Systems, Inc. (2005) Summary page 4.

## Indications for use
Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes are sterile electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K152984
Methodology: https://510kreport.com/methodology