510(k) · Cleared
ClearedDiscoverEEG System, Model DE-401
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurowave Systems, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jun 23, 2015 as substantially equivalent to K092477 (Neurowave Systems, Inc., 2010) and 1 other predicate after a 266-day review. Its family tree reaches back 8 generations to 1996. 5 later devices descend from it.
- Decided
- Jun 23, 2015
- Review
- 266 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K963644 (1996). 27 ancestors in all, the oldest K871179 (1987). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 7 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 6 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 5 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 4 generations backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 3 generations backK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- 2 generations backK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- 1 generation backK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- This deviceK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK192549 Byteflies KitByteflies NV · 2020
- Descendant · 2 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251550 NX01 (NX01)Naox Technologies Sas · 2025
- Descendant · 2 generations on · 0 of its ownK240593 VEEGix EEG SystemNeuroServo, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · cites it directly2descendants
- K192549Byteflies KitByteflies NV · 2020 · cites it directly1descendant
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 2 generations on0descendants
- K251550NX01 (NX01)Naox Technologies Sas · 2025 · 2 generations on0descendants
- K240593VEEGix EEG SystemNeuroServo, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −7 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −6 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −5 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −4 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −3 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| −2 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| −1 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| 0 (this device) | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +1 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +1 | K192549 | Byteflies Kit | Byteflies NV | 2020 | — |
| +2 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
| +2 | K251550 | NX01 (NX01) | Naox Technologies Sas | 2025 | — |
| +2 | K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 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 |
|---|---|---|---|
| * | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Summary page 4…gy 3. Legally Marketed Predicate Device 510(k) Product Trade Name Manufacturer Number Code K092477 OMC NeuroFAST Monitoring NeuroWave Systems, Inc. System, Model NF-201 K101830… | 2010 |
| * | K101830 | Zmachine, Model DT-100Summary page 4…Manufacturer Number Code K092477 OMC NeuroFAST Monitoring NeuroWave Systems, Inc. System, Model NF-201 K101830 OLV, Zmachine Consolidated Research of OMC Richm… | 2011 |
What descends from it? (5)
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 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K213299 (Pascall Systems, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject’s brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142834: DiscoverEEG System, Model DE-401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142834
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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