510(k) · Cleared
ClearedG.Usbamp
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 May 2, 2006 as substantially equivalent to K023536 (Neuroscan, 2003) after a 39-day review. Its family tree reaches back 2 generations to 2000. 19 later devices descend from it.
- Decided
- May 2, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001564 (2000). 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 1 generation backK023536 NuampsNeuroscan · 2003
- This deviceK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- Descendant · cites it directly · 13 of its ownK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · cites it directly · 4 of its ownK123255 g.HIampG.Tec Medical Engineering GmbH · 2012
- Descendant · 2 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 2 generations on · 2 of its ownK171669 g.Nautilus PROG.Tec Medical Engineering GmbH · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · cites it directly13descendants
- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
- K123255g.HIampG.Tec Medical Engineering GmbH · 2012 · cites it directly4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 2 generations on3descendants
- K171669g.Nautilus PROG.Tec Medical Engineering GmbH · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −1 | K023536 | Nuamps | Neuroscan | 2003 | — |
| 0 (this device) | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| +1 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| +1 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +1 | K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012 | — |
| +2 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +2 | K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K023536 | NuampsSummary page 1…n 21 CER 882.1835) Classification Number: GWL 807.92(a)(3) Predicate Device(s) Neuroscan Nuamps K023536 510(k) Summary g.tec medical engineering GmbH g.USBamp 807.92(a)(4) Device… | 2003 |
What descends from it? (19)
See all 193 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 6 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090957 (I2s Micro Implantable Systems, LLC, 2009) has gone furthest, with 13 descendants of its own.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060803: G.Usbamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060803
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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