510(k) · Cleared
ClearedNeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurowave Systems, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Oct 29, 2010 as substantially equivalent to K082886 (Brainscope Company, Inc., 2009) and 1 other predicate after a 443-day review. Its family tree reaches back 7 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 29, 2010
- Review
- 443 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963644 (1996). 24 ancestors in all, the oldest K871179 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 6 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 5 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 4 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 3 generations backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 2 generations backK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- 1 generation backK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- This deviceK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK192549 Byteflies KitByteflies NV · 2020
- Descendant · 3 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK251550 NX01 (NX01)Naox Technologies Sas · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · cites it directly5descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 2 generations on2descendants
- K192549Byteflies KitByteflies NV · 2020 · 2 generations on1descendant
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 3 generations on0descendants
- K251550NX01 (NX01)Naox Technologies Sas · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −6 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −5 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −4 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −3 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −2 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| −1 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| 0 (this device) | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +1 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +2 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +2 | K192549 | Byteflies Kit | Byteflies NV | 2020 | — |
| +3 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
| +3 | 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 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K082886 | Zoom-100DCSummary page 1…510(k) Producet Trade Name Manufacturer Number Code I K082886 OLT ZOOM-100DC Brainscope Cornpany ,Inc. K072382 GWQ Model 1-2000 Monitor Infi… | 2009 |
| * | K072382 | Model I-2000 MonitorSummary page 1…mber Code I K082886 OLT ZOOM-100DC Brainscope Cornpany ,Inc. K072382 GWQ Model 1-2000 Monitor Infinite Biomedical Technologies 4. Description of Device The NeuroFAST Moni… | 2008 |
| † | K781430 | Pregelled Disposable E.K.G. Electrode | 1978 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142834 | DiscoverEEG System, Model DE-401 | 2015 | 5 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K142834 (Neurowave Systems, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K082886.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, [CU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092477
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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