510(k) · Cleared
ClearedBrainmaster 2E Module and Software Biofeedback Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainmaster · HCC Device, Biofeedback
Cleared on May 19, 1999 as substantially equivalent to K961645 (Lexicor Medical Technology, Inc., 1996) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- May 19, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920038 (1995). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920038 Neurosearch-4Lexicor · 1995
- 1 generation backK961645 MRS-2DLexicor Medical Technology, Inc. · 1996
- This deviceK990538 Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999
- Descendant · cites it directly · 3 of its ownK073557 Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK122879 EEGER4 Model 4.3Eeg Software, LLC · 2013
- Descendant · cites it directly · 0 of its ownK252923 IASIS i2 Relaxation Neurofeedback SystemIasis Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
Most influential descendants
Showing 5 of 5 · See all- K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · cites it directly3descendants
- K122879EEGER4 Model 4.3Eeg Software, LLC · 2013 · cites it directly1descendant
- K252923IASIS i2 Relaxation Neurofeedback SystemIasis Technologies · 2026 · cites it directly0descendants
- K222101PrismGraymatters Health, Ltd. · 2023 · 2 generations on0descendants
- K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920038 | Neurosearch-4 | Lexicor | 1995 | — |
| −1 | K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996 | — |
| 0 (this device) | K990538 | Brainmaster 2E Module and Software Biofeedback Device | Brainmaster | 1999 | — |
| +1 | K073557 | Eeg Neuroamp, Model CS10137 | Corscience GmbH & Co. KG | 2008 | 1 |
| +1 | K122879 | EEGER4 Model 4.3 | Eeg Software, LLC | 2013 | — |
| +1 | K252923 | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | 2026 | — |
| +2 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
| +2 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K961645 | MRS-2DSummary page 1…Ph.D. October 1998 Name of the Device: The BrainMaster™ 2E Predicate Device Information: 1. The Lexicor NRS-2D, Lexicor Medical Technology, Inc., Boulder, Colorado, K#961645. 2. Stoelting AT 62 EEG, Stoelting Company, K#965006. Device Description: Executive Summary and Device Description: This two-… | 1996 |
| * | K965006 | AT 62 Eeg (a.K.a the a;Pha-Theta Trainer)Summary page 1…er™ 2E Predicate Device Information: 1. The Lexicor NRS-2D, Lexicor Medical Technology, Inc., Boulder, Colorado, K#961645. 2. Stoelting AT 62 EEG, Stoelting Company, K#965006. Device Description: Executive Summary and Device Description: This two-channel digital Biofeedback/EEG device uses industry-a… | 1997 |
What descends from it? (5)
3 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 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073557 (Corscience GmbH & Co. KG, 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient’s increase in alpha activity as an indicator of achieving a state of relaxation.
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/K990538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990538: Brainmaster 2E Module and Software Biofeedback Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990538
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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