# K905632: Nicolet Mapleleaf System

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Instrument Corp.
- Decided: Jun 7, 1991 after 172 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
94 later devices descend from it; 1 cites it directly.
1 of 95 devices in its family (counting itself) has 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
- K991054: Bravo Multi-Modality System (1999), 93 descendants of its own
- K031510: Nim-Spine (2003), 40 descendants of its own
- K112052: Carefusion Nicolet Edx (2012), 30 descendants of its own
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own

Source page: https://510kreport.com/device/K905632
Methodology: https://510kreport.com/methodology