# K950314: Dantec Monopolar Lumen Electrode (13R18 and 13R19)

- Pathway: 510(k) (Traditional)
- Applicant: Dantec Medical, Inc.
- Decided: Mar 25, 1996 after 424 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
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx (2001), 14 descendants of its own
- K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX (2002), 13 descendants of its own
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (2006), 12 descendants of its own
- K072123: Homewave Neuromodulations Pain Therapy Device (2008), 11 descendants of its own
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), 9 descendants of its own

Source page: https://510kreport.com/device/K950314
Methodology: https://510kreport.com/methodology