510(k) · Cleared
Clearedg.Nautilus PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.Tec Medical Engineering GmbH · GWL Amplifier, Physiological Signal
Cleared on Jul 5, 2017 as substantially equivalent to K123255 (G.Tec Medical Engineering GmbH, 2012) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1978. 2 later devices descend from it.
- Decided
- Jul 5, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K780045 (1978). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 3 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 2 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 1 generation backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- This deviceK171669 g.Nautilus PROG.Tec Medical Engineering GmbH · 2017
- Descendant · cites it directly · 1 of its ownK203331 Quick-20mCgx, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK232210 X-trodes System MX-Trodes · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −3 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −2 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −1 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| 0 (this device) | K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017 | — |
| +1 | K203331 | Quick-20m | Cgx, LLC | 2021 | — |
| +2 | K232210 | X-trodes System M | X-Trodes | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 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 |
|---|---|---|---|
| * | K123255 | g.HIampSummary page 4…Product Codes: GWL, GXY 807.92(a)(3) Predicate Device(s) g.tec medical engineering GmbH g.HIamp K123255 Electro-cap International Inc. Electro-Cap System K112319 Page 1 of 6 === P… | 2012 |
| * | K112319 | Electro-Cap SystemSummary page 4…Predicate Device(s) g.tec medical engineering GmbH g.HIamp K123255 Electro-cap International Inc. Electro-Cap System K112319 Page 1 of 6 807.92(a)(4) Devic… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203331 | Quick-20m | 2021 | 1 |
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 39 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K203331 (Cgx, LLC, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K123255.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171669: g.Nautilus PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171669
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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