# K873535: Nicolet Expert Sleep/Wake Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical Instruments
- Decided: Oct 26, 1987 after 55 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
65 later devices descend from it; 2 cite it directly.
0 of 66 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
- K955841: Sleep System for Clinics & Research (1997), 63 descendants of its own
- K072201: Compumedics Somte PSG Recording System (2008), 48 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K072014: Vitascore (2007), 40 descendants of its own
- K082968: Apneicare Connection Center/Internet Analysis (2009), 39 descendants of its own

Source page: https://510kreport.com/device/K873535
Methodology: https://510kreport.com/methodology