510(k) · Cleared
ClearedNeuron-Spectrum-4/P with Neuron-Spectrum.Net Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurosoft, Ltd. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Jun 19, 2015 as substantially equivalent to K122196 (Blackrock Neuromed, LLC, 2013) and 4 other predicates after a 540-day review. Its family tree reaches back 8 generations to 1989. 1 later device descends from it.
- Decided
- Jun 19, 2015
- Review
- 540 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K884937 (1989). 45 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 7 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 6 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 5 generations backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- 4 generations backK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- 3 generations backK050425 Aura-PSGAstro-Med, Inc. · 2005
- 2 generations backK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- 1 generation backK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- This deviceK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK220254 Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −7 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −6 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −5 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| −4 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| −3 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| −2 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| −1 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| 0 (this device) | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +1 | K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K122196 | Cervello Bio-Potential Signal Acquistion System Product FamilySummary page 5…on. TM CERVELLO BIO- POTENTIAL Blackrock Neuromed, LLC SIGNAL K122196 Overall functions ACQUISITION SYSTEM Persyst 12 Eeg Review And Analysis Persyst Developme… | 2013 |
| * | K132306 | Persyst 12 Eeg Review and Analysis SoftwareSummary page 5…K122196 Overall functions ACQUISITION SYSTEM Persyst 12 Eeg Review And Analysis Persyst Development Corp K132306 Software functions Software Alice 5 System Respironics , INC. K040595 Pol… | 2013 |
| * | K040595 | ALICE 5Summary page 5…Analysis Persyst Development Corp K132306 Software functions Software Alice 5 System Respironics , INC. K040595 Polysomnographyfunction Focus EMG Device TELEEMG, LLC K102610 Auditory stimulato… | 2004 |
| * | K102610 | Focus Emg DeviceSummary page 5…Alice 5 System Respironics , INC. K040595 Polysomnographyfunction Focus EMG Device TELEEMG, LLC K102610 Auditory stimulator Neurofax m EEG-9100 Nihon Kohden Corporation K011204 Photic Stimulator… | 2011 |
| * | K011204 | Neurofax, Models Eeg-1100A, Eeg-9100ASummary page 5…ion Focus EMG Device TELEEMG, LLC K102610 Auditory stimulator Neurofax m EEG-9100 Nihon Kohden Corporation K011204 Photic Stimulator DEVICE DESCRIPTION The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neur… | 2001 |
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 |
|---|---|---|---|
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | 2022 | 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 26 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K220254 (Neurosoft, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122196.
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 digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software…
Read the full statement (175 words)
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG),1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133995
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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