510(k) · Cleared
Recalled · Class II · 2012Eeg Neuroamp, Model CS10137
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corscience GmbH & Co. KG · HCC Device, Biofeedback
Cleared on Feb 28, 2008 as substantially equivalent to K903497 (Thought Technology, Ltd., 1991) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- HCC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920038 (1995). 5 ancestors in all, the oldest K903497 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK920038 Neurosearch-4Lexicor · 1995
- 2 generations backK961645 MRS-2DLexicor Medical Technology, Inc. · 1996
- 1 generation backK990538 Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999
- This deviceK073557 Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008
- Descendant · cites it directly · 1 of its ownK122879 EEGER4 Model 4.3Eeg Software, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920038 | Neurosearch-4 | Lexicor | 1995 | — |
| −2 | K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996 | — |
| −1 | K990538 | Brainmaster 2E Module and Software Biofeedback Device | Brainmaster | 1999 | — |
| 0 (this device) | K073557 | Eeg Neuroamp, Model CS10137 | Corscience GmbH & Co. KG | 2008 | — |
| +1 | K122879 | EEGER4 Model 4.3 | Eeg Software, LLC | 2013 | — |
| +2 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
| +1 | 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 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K903497 | Flexcomp DSP & ProcompSummary page 2…t Technology Ltd., Montreal, Canada BrainMaster Technologies, Inc., Oakwood Village, OH 44146, formerly: Cleveland, OH 44124 5.8.3 Predicate Device 510(k)# ProComp: K903497 BrainMaster: K990538 Title Premarket Notification for EEG NeuroAmp Document Name Iss… | 1991 |
| * | K990538 | Brainmaster 2E Module and Software Biofeedback DeviceSummary page 2…ntreal, Canada BrainMaster Technologies, Inc., Oakwood Village, OH 44146, formerly: Cleveland, OH 44124 5.8.3 Predicate Device 510(k)# ProComp: K903497 BrainMaster: K990538 Title Premarket Notification for EEG NeuroAmp Document Name Issue… | 1999 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2012 | Class II | Z-0526-2013 | Labeling False and Misleading | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122879 (Eeg Software, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K903497.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software. For purposes of this training task, information for feedback maybe derived from one or two channels of EEG and from as many as three channels of pripheral physiology measures such as are conventionally used in biofeedback The EEG NeuroAmp is intended to be used in the office by…
Read the full statement (131 words)
The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.
For purposes of this training task, information for feedback maybe derived from one or two channels of EEG and from as many as three channels of pripheral physiology measures such as are conventionally used in biofeedback
The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.
The EEG NeuroAmp is not intended for diagnostic purposes.
"Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the law of the State in which he practices to use or order the use of the device."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073557 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073557: Eeg Neuroamp, Model CS10137.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073557
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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