510(k) · Cleared
Recalled · Class II · 2018Nervus Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taugagreining HF · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Jul 12, 2002 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 12, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- OLV
- Recalls
- 2
- Predicates
- 0
18 later devices descend from it, 6 citing it directly.
- This deviceK021185 Nervus MonitorTaugagreining HF · 2002
- Descendant · cites it directly · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · cites it directly · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · cites it directly14descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · cites it directly8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · cites it directly7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 2 generations on5descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021185 | Nervus Monitor | Taugagreining HF | 2002 | — |
| +1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +1 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +1 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +2 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (18)
See all 186 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2018 | Class II | Z-2568-2018 | Software design | Potential to be able to import an ambulatory exam for a patient for which the exam was not started. |
| Sep 11, 2007 | Not classified | Z-0126-2008 | Component design/selection | Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080217 (Moberg Research, Inc., 2008) has gone furthest, with 14 descendants of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients.
The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021185: Nervus Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021185
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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