510(k) · Cleared
ClearedEEGER4 Model 4.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eeg Software, LLC · HCC Device, Biofeedback
Cleared on Feb 6, 2013 as substantially equivalent to K990538 (Brainmaster, 1999) and 2 other predicates after a 140-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Feb 6, 2013
- Review
- 140 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K920038 (1995). 6 ancestors in all, the oldest K903497 (1991). 1 later device descends from it, 1 citing it directly.
- 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 deviceK122879 EEGER4 Model 4.3Eeg Software, LLC · 2013
- Descendant · cites it directly · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222101PrismGraymatters Health, Ltd. · 2023 · cites it directly0descendants
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) | K122879 | EEGER4 Model 4.3 | Eeg Software, LLC | 2013 | — |
| +1 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K990538 | Brainmaster 2E Module and Software Biofeedback DeviceSummary page 1…CFR §882-5050) Predicate devices: Device 510(k) Product Manufacturer code Brainmaster2E K990538 HCC BrainMaster Technologies, Inc ,Bedford, OH NeuroAmp K073557 HCC Corsoience GmbH & Co. KG, Germany… | 1999 |
| * | K073557 | Eeg Neuroamp, Model CS10137Summary page 1…Manufacturer code Brainmaster2E K990538 HCC BrainMaster Technologies, Inc ,Bedford, OH NeuroAmp K073557 HCC Corsoience GmbH & Co. KG, Germany Proomp K903497 HCC Thought Technology LTD., Montreal,Quebec… | 2008 |
| * | K903497 | Flexcomp DSP & ProcompSummary page 1…K990538 HCC BrainMaster Technologies, Inc ,Bedford, OH NeuroAmp K073557 HCC Corsoience GmbH & Co. KG, Germany Proomp K903497 HCC Thought Technology LTD., Montreal,Quebec Device Description: This software-only component of an EEG biofeedb… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222101 | Prism | 2023 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K222101 (Graymatters Health, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K990538.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
This device is to be used for general relaxation training when used with supported amplifier/encoders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122879: EEGER4 Model 4.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122879
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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