510(k) · Cleared
ClearedByteflies Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byteflies NV · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Jun 22, 2020 as substantially equivalent to K142834 (Neurowave Systems, Inc., 2015) after a 279-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Jun 22, 2020
- Review
- 279 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963644 (1996). 28 ancestors in all, the oldest K871179 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations between
- 3 generations backK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- 2 generations backK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- 1 generation backK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- This deviceK192549 Byteflies KitByteflies NV · 2020
- Descendant · cites it directly · 0 of its ownK251550 NX01 (NX01)Naox Technologies Sas · 2025
Show all 9 generations
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 8 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 7 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 6 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 5 generations backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 4 generations backK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- 3 generations backK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- 2 generations backK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- 1 generation backK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- This deviceK192549 Byteflies KitByteflies NV · 2020
Most influential descendants
Showing 1 of 1 · See all- K251550NX01 (NX01)Naox Technologies Sas · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −8 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −7 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −6 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −5 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −4 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| −3 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| −2 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| −1 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| 0 (this device) | K192549 | Byteflies Kit | Byteflies NV | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K142834 | DiscoverEEG System, Model DE-401Summary page 4…lass II) Product Code OMC Regulation Number 21 CFR 882.1400 Predicate Device NeuroWave Systems Inc, DiscoverEEG System, Model DE-401 (K142834, product code: OMC) Description of Device The Byteflies Kit is a wearable medical device for continuous recording of non-invas… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251550 | NX01 (NX01) | 2025 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K251550 (Naox Technologies Sas, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142834.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to
acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction and interpretation of a licensed medical professional. The Byteflies Kit does not provide any diagnostic conclusions about the patient’s condition.
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/K192549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192549: Byteflies Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192549
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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