510(k) · Cleared
ClearedNatus NeuroWorks
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) · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on May 18, 2020 as substantially equivalent to K180421 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2018) and 2 other predicates after a 46-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it.
- Decided
- May 18, 2020
- Review
- 46 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K875179 (1988). 51 ancestors in all, the oldest K791580 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 7 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 6 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 5 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 4 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 3 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 2 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 1 generation backK173366 NicoletOneNatus Neurology Incorporated · 2018
- This deviceK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · cites it directly · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
Most influential descendants
Showing 1 of 1 · See all- K251881HippoMind (v1.0)Hippoclinic · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −7 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −6 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −5 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −4 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −1 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| 0 (this device) | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +1 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 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 OMB? 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 OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K180421 | Natus NeuroWorksSummary page 5…0(k) Predicate Equivalent Devices: Number Manufacturer / Model Natus NeuroWorks K180421 Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)… | 2018 |
| * | K173366 | NicoletOneSummary page 5…Circle Oakville, Ontario, L6H 5S1 Canada NicoletOne K173366 Natus Nurology Inc. Moberg CNS K080217 Moberg. Device Descrip… | 2018 |
| * | K080217 | Component Neuromonitoring SystemSummary page 5…ntario, L6H 5S1 Canada NicoletOne K173366 Natus Nurology Inc. Moberg CNS K080217 Moberg. Device Description: Natus NeuroWorks is electroencephalography (EEG) software that displays physiologica… | 2008 |
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 |
|---|---|---|---|
| K251881 | HippoMind (v1.0) | 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 32 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 11 of the 51 ancestors have a recall of any class.
- Of its descendants, K251881 (Hippoclinic, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. * The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the…
Read the full statement (267 words)
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified
medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information.
The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals.
* The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater
than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified
clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage
according to the standard 10/20 system.
* The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater
than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified
clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage
according to the standard 10/20 system.
+ aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trending functionalities
included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event
marking function of Neuroworks is not applicable to these analysis features.
» NeuroWorks also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to
help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not
applicable to DSA.
» This device does not provide any diagnostic conclusion about the patient’s condition to the user.
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/K200878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200878: Natus NeuroWorks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200878
Report an extraction error
Are you the manufacturer?
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