# K010019: Sterile Subdermal Needle Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Mar 19, 2001 after 76 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Apr 28, 2006 · Not classified · Z-1254-06: The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the p

Source page: https://510kreport.com/device/K010019
Methodology: https://510kreport.com/methodology