510(k) · Cleared
ClearedNeurolink IP Model: PK1117
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 9, 2010 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 9, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK100683 Neurolink IP Model: PK1117Natus Medical Incorporated · 2010
- Descendant · cites it directly · 4 of its ownK143440 Natus QuantumNatus Medical Incorporated · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK180290 Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK180181 Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · 2018
- Descendant · 3 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
- Descendant · 2 generations on · 0 of its ownK181466 Cadwell Zenith SystemCadwell Industries, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143440Natus QuantumNatus Medical Incorporated · 2015 · cites it directly4descendants
- K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · 2 generations on1descendant
- K180181Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · 2018 · 2 generations on1descendant
- K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020 · 3 generations on0descendants
- K181466Cadwell Zenith SystemCadwell Industries, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100683 | Neurolink IP Model: PK1117 | Natus Medical Incorporated | 2010 | — |
| +1 | K143440 | Natus Quantum | Natus Medical Incorporated | 2015 | 1 |
| +2 | K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | 1 |
| +2 | K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018 | — |
| +3 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
| +2 | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143440 (Natus Medical Incorporated, 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100683 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100683: Neurolink IP Model: PK1117.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100683
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026