510(k) · Cleared
ClearedNatus BrainWatch System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Nov 19, 2024 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 1978.
- Decided
- Nov 19, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K780045 (1978). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 5 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 4 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 3 generations backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- 2 generations backK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- 1 generation backK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- This deviceK242930 Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −5 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −4 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −3 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| −2 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| −1 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| 0 (this device) | K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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 6…SYSTEM Classification Name: Reduced montage standard electroencephalograph Product code: OMC, GXY Device Class: II Predicate Device: Ceribell Pocket EEG Device (K170363), Ceribell Instant EEG Headband (K210805) Description: Overview: Natus BrainWatch System The Natus BrainWatch system is a rel… | 2017 |
| * | K210805 | Ceribell Instant EEG HeadbandSummary page 6…tage standard electroencephalograph Product code: OMC, GXY Device Class: II Predicate Device: Ceribell Pocket EEG Device (K170363), Ceribell Instant EEG Headband (K210805) Description: Overview: Natus BrainWatch System The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device… | 2021 |
| † | K203331 | Quick-20m | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 46 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- None of the 11 ancestors has a recall.
- 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. 2024, 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 Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and
store EEG signals and present these signals visually to assist trained medical staff in making
neurological diagnoses in patients aged 2 years and older.
The device does not provide any diagnostic conclusions about the subject's condition and does not
provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is
intended for use within a professional healthcare facility or clinical research environment. The Natus
BrainWatch Headband is intended for single-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242930: Natus BrainWatch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242930
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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