510(k) · Cleared
ClearedNurochek System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryptych Pty, Ltd. · GWE Stimulator, Photic, Evoked Response
Cleared on Apr 23, 2020 as substantially equivalent to K113785 (Anschel Technology, Inc., 2012) and 1 other predicate after a 36-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Apr 23, 2020
- Review
- 36 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873535 (1987). 25 ancestors in all, the oldest K831231 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 6 generations backK072014 VitascoreVitascore B.V. · 2007
- 5 generations backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- 4 generations backK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- 3 generations backK120447 X4Advanced Brain Monitoring, Inc. · 2012
- 2 generations backK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- This deviceK200705 Nurochek SystemCryptych Pty, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −7 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −6 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −5 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| −4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWE? 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 GWE device
- #1 K211643 Vision Monitor - MonpackONEscore 5.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113785 | Adherent Visual Stimulator GogglesSummary page 4…Cryptych Pty Ltd Preparation Date: March 05, 2020 Predicate Devices: SightSaver Visual Stimulator by Anschel Technology INC.(K113785) X-Series System by Advanced Brain Monitoring (K131383) DEVICE DESCRIPTION The Nuroche… | 2012 |
| * | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareSummary page 4…: SightSaver Visual Stimulator by Anschel Technology INC.(K113785) X-Series System by Advanced Brain Monitoring (K131383) DEVICE DESCRIPTION The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, t… | 2013 |
| † | K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 25 ancestors has a recall of any class.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GWE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GWE
Too few GWE 510(k)s in any year since 2007 to give a median.
Recalls per year · GWE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWE
1in 2025
MAUDE reports naming product code GWE, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nurochek System is intended for prescription use in healthcare facilities or clinical research environments for subjects ages 14 years and older. The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200705: Nurochek System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200705
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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