# K022914: Rhythmlink International Subdermal Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Dec 20, 2002 after 108 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870795 (1987). 19 ancestors in all.
50 later devices descend from it; 8 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990015: Electrode Needles, Technomed Europe (1999) Summary page 1.
- K010019: Sterile Subdermal Needle Electrodes, Nicolet Biomedical, Inc. (2001)

## Most influential descendants
- 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
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own

## Indications for use
Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Source page: https://510kreport.com/device/K022914
Methodology: https://510kreport.com/methodology