# K100683: Neurolink IP Model: PK1117

- Pathway: 510(k) (Special)
- Applicant: Natus Medical Incorporated
- Decided: Apr 9, 2010 after 30 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143440: Natus Quantum (2015), 4 descendants of its own
- K180290: Natus Brain Monitor Amplifier (2018), 1 descendant of its own
- K180181: Natus Quantum (2018), 1 descendant of its own
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own
- K181466: Cadwell Zenith System (2018), 0 descendants of its own

## Indications for use
The Neurol-ink IP is intended to be used as an electroencephalograph: to acquire, digitize and transmit electroencephalographic and other physiological signals (such as purse and oximetry signals) for EEG studies in research and clinical environments.

Source page: https://510kreport.com/device/K100683
Methodology: https://510kreport.com/methodology