# K923315: Nicolet Ark System

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Instrument Corp.
- Decided: Nov 23, 1992 after 139 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
1 of 42 devices in its family (counting itself) has 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
- K031510: Nim-Spine (2003), 40 descendants of its own
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162313: NuVasive Next Generation NVM5 System (2017), 7 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own

Source page: https://510kreport.com/device/K923315
Methodology: https://510kreport.com/methodology