510(k) · Cleared
ClearedMRS-2D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexicor Medical Technology, Inc. · HCC Device, Biofeedback
Cleared on Oct 31, 1996 as substantially equivalent to K920038 (Lexicor, 1995) after a 185-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Oct 31, 1996
- Review
- 185 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920038 (1995). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920038 Neurosearch-4Lexicor · 1995
- This deviceK961645 MRS-2DLexicor Medical Technology, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK990538 Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999
- Descendant · 2 generations on · 3 of its ownK073557 Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK122879 EEGER4 Model 4.3Eeg Software, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK252923 IASIS i2 Relaxation Neurofeedback SystemIasis Technologies · 2026
- Descendant · 3 generations on · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K990538Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999 · cites it directly5descendants
- K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · 2 generations on3descendants
- K122879EEGER4 Model 4.3Eeg Software, LLC · 2013 · 2 generations on1descendant
- K252923IASIS i2 Relaxation Neurofeedback SystemIasis Technologies · 2026 · 2 generations on0descendants
- K222101PrismGraymatters Health, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920038 | Neurosearch-4 | Lexicor | 1995 | — |
| 0 (this device) | K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996 | — |
| +1 | K990538 | Brainmaster 2E Module and Software Biofeedback Device | Brainmaster | 1999 | — |
| +2 | K073557 | Eeg Neuroamp, Model CS10137 | Corscience GmbH & Co. KG | 2008 | 1 |
| +2 | K122879 | EEGER4 Model 4.3 | Eeg Software, LLC | 2013 | — |
| +2 | K252923 | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | 2026 | — |
| +3 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K920038 | Neurosearch-4Summary page 3…f the patient. Operation and Usage Please refer to the Biolex Software Manual for complete operating instructions prior to use. PREDICATE DEVICE Lexicor NRS-4, 510(k) K920038 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS System Block Diagram Patient Computer Interface Acquisition interface Personal 0 D O g… | 1995 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990538 | Brainmaster 2E Module and Software Biofeedback Device | 1999 | 5 |
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?
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?
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex 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/K961645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961645: MRS-2D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961645
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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