510(k) · Cleared
ClearedCrystal-Eeg Model 10 (Model 10)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Medical Devices, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on May 22, 1997 after an 87-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- May 22, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK970672 Crystal-Eeg Model 10 (Model 10)Cleveland Medical Devices, Inc. · 1997
- Descendant · cites it directly · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · cites it directly11descendants
- K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010 · 2 generations on6descendants
- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · 3 generations on5descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 2 generations on5descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970672 | Crystal-Eeg Model 10 (Model 10) | Cleveland Medical Devices, Inc. | 1997 | — |
| +1 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +2 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +3 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +2 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +3 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 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? (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 |
|---|---|---|---|
| * | — | Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082886 | Zoom-100DC | 2009 | 11 |
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?
- Of its descendants, K082886 (Brainscope Company, Inc., 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Crystal-EEG Model-10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.
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/K970672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970672: Crystal-Eeg Model 10 (Model 10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970672
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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