510(k) · Cleared
ClearedNeurosteer EEG Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurosteer, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Oct 24, 2022 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 1 other predicate after a 146-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it.
- Decided
- Oct 24, 2022
- Review
- 146 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830295 (1983). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 1 generation backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- This deviceK221563 Neurosteer EEG RecorderNeurosteer, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232779 Quex ED; Quex SQx World, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK240593 VEEGix EEG SystemNeuroServo, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −1 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| 0 (this device) | K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | 2022 | — |
| +1 | K232779 | Quex ED; Quex S | Qx World, Ltd. | 2024 | — |
| +1 | K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K170363 | Ceribell Pocket EEG DeviceSummary page 4…FR 882.1400 Device Class: Class II Product Code: OMC Predicate Devices Predicate devices: Ceribell, Inc. Ceribell Pocket EEG Device (K170363) Ceribell, Inc. Ceribell Instant EEG Headband (K171459) Reference device: Corscience gmBH EE… | 2017 |
| * | K171459 | Ceribell Instant EEG HeadbandSummary page 4…edicate Devices Predicate devices: Ceribell, Inc. Ceribell Pocket EEG Device (K170363) Ceribell, Inc. Ceribell Instant EEG Headband (K171459) Reference device: Corscience gmBH EEG/ERP NeuroAmp (K193159) Device Description The Neurosteer bra… | 2017 |
| † | K193159 | NeuroAmp II, NeuroAmp II.5s | 2020 |
What descends from it? (2)
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)
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 39 years and passes through 3 companies; a new generation was cleared every 34.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K232779 (Qx World, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K170363.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
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/K221563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221563: Neurosteer EEG Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221563
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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