510(k) · Cleared
ClearedNeuroAmp II, NeuroAmp II.5s
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corscience GmbH & Co. KG · GWQ Full-Montage Standard Electroencephalograph
Cleared on Dec 30, 2020 as substantially equivalent to K143233 (Mitsar Co., Ltd., 2015) and 2 other predicates after a 411-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 30, 2020
- Review
- 411 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K920038 (1995). 22 ancestors in all, the oldest K903497 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK920038 Neurosearch-4Lexicor · 1995
- 3 generations backK961645 MRS-2DLexicor Medical Technology, Inc. · 1996
- 2 generations backK990538 Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999
- 1 generation backK073557 Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · Recalled
- This deviceK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920038 | Neurosearch-4 | Lexicor | 1995 | — |
| −3 | K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996 | — |
| −2 | K990538 | Brainmaster 2E Module and Software Biofeedback Device | Brainmaster | 1999 | — |
| −1 | K073557 | Eeg Neuroamp, Model CS10137 | Corscience GmbH & Co. KG | 2008 | 1 |
| 0 (this device) | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 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? (3)
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 |
|---|---|---|---|
| * | K143233 | Mitsar-EEGSummary page 5…2568 Bristol Circle, Oakville, ON L6H5S1, Canada Corscience GmbH & Co. KG, Hartmannstrasse 65, 91052 Erlangen, Germany 7.3. Predicate Device 510(k)# Mitsar EEG: K143233 Natus Brain Monitor, Embla Dx series: K180290 EEG NeuroAmp: K073557… | 2015 |
| * | K180290 | Natus Brain Monitor AmplifierSummary page 5…da Corscience GmbH & Co. KG, Hartmannstrasse 65, 91052 Erlangen, Germany 7.3. Predicate Device 510(k)# Mitsar EEG: K143233 Natus Brain Monitor, Embla Dx series: K180290 EEG NeuroAmp: K073557 2 =… | 2018 |
| * | K073557 | Eeg Neuroamp, Model CS10137Summary page 5…o. KG, Hartmannstrasse 65, 91052 Erlangen, Germany 7.3. Predicate Device 510(k)# Mitsar EEG: K143233 Natus Brain Monitor, Embla Dx series: K180290 EEG NeuroAmp: K073557 2 Title Pr… | 2008 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 4 other devices also cite its predicate K143233.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 EEG NeuroAmp I1.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.…
Read the full statement (215 words)
The EEG NeuroAmp I1.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp I1.5s can also be used for biofeedback and relaxation purposes. For purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp I1.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193159: NeuroAmp II, NeuroAmp II.5s.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193159
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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