510(k) · Cleared
ClearedNX01 (NX01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naox Technologies Sas · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Nov 25, 2025 as substantially equivalent to K192549 (Byteflies NV, 2020) after a 188-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Nov 25, 2025
- Review
- 188 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K963644 (1996). 29 ancestors in all, the oldest K871179 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 6 generations between
- 3 generations backK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- 2 generations backK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- 1 generation backK192549 Byteflies KitByteflies NV · 2020
- This deviceK251550 NX01 (NX01)Naox Technologies Sas · 2025
Show all 10 generations
- Root · 10 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 9 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 8 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 7 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 6 generations backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 5 generations backK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- 4 generations backK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- 3 generations backK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- 2 generations backK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- 1 generation backK192549 Byteflies KitByteflies NV · 2020
- This deviceK251550 NX01 (NX01)Naox Technologies Sas · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −9 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −8 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −7 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −6 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −5 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| −4 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| −3 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| −2 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| −1 | K192549 | Byteflies Kit | Byteflies NV | 2020 | — |
| 0 (this device) | K251550 | NX01 (NX01) | Naox Technologies Sas | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 K261101 Ceribell Monitorscore 12.8 · 5 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 |
|---|---|---|---|
| * | K192549 | Byteflies KitSummary page 11…le 3 – Primary Predicate device Predicate Device Tradename Byteflies Kit 510(k) K192549 Regulation number 21 CFR 882.1400 Regulation Name Electroencephalograph Product Code O… | 2020 |
| † | K001781 | Curry Multimodal Neuroimaging Software | 2001 |
| † | K222002 | Persyst 15 EEG Review and Analysis Software | 2022 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 29 ancestors have a recall of any class.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional. NX01 does not provide any diagnostic conclusions about the patient's condition.
The NX01 is intended for use with adult and pediatric patients (6+).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251550: NX01 (NX01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251550
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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