510(k) · Cleared
Clearedg.HIamp
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 Dec 20, 2012 as substantially equivalent to K060803 (G.Tec Medical Engineering GmbH, 2006) after a 63-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001564 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 2 generations backK023536 NuampsNeuroscan · 2003
- 1 generation backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- This deviceK123255 g.HIampG.Tec Medical Engineering GmbH · 2012
- Descendant · cites it directly · 2 of its ownK171669 g.Nautilus PROG.Tec Medical Engineering GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK203331 Quick-20mCgx, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK232210 X-trodes System MX-Trodes · 2024
- Descendant · cites it directly · 0 of its ownK191432 cortiQ PROG.Tec Medical Engineering GmbH · 2020
Most influential descendants
Showing 4 of 4 · See all- K171669g.Nautilus PROG.Tec Medical Engineering GmbH · 2017 · cites it directly2descendants
- K203331Quick-20mCgx, LLC · 2021 · 2 generations on1descendant
- K232210X-trodes System MX-Trodes · 2024 · 3 generations on0descendants
- K191432cortiQ PROG.Tec Medical Engineering GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −2 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −1 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| 0 (this device) | K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012 | — |
| +1 | K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017 | — |
| +2 | K203331 | Quick-20m | Cgx, LLC | 2021 | — |
| +3 | K232210 | X-trodes System M | X-Trodes | 2024 | — |
| +1 | K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K060803 | G.UsbampSummary page 1…Product Code: OWL 807.92(a)(3) Predicate Device(s) g.tec medical engineering GmbH g.USBamp K060803 g.Hlamp 5 10O(k) Premarket Notification g.tec medical engineering GmbH 807.92(a)(4… | 2006 |
What descends from it? (4)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171669 (G.Tec Medical Engineering GmbH, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K060803.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMO), electrooculogram (EOG), and electrocardiogram (ECG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123255: g.HIamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123255
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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