510(k) · Cleared
ClearedNicoletOne
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Neurology Incorporated · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Jul 20, 2018 as substantially equivalent to K012976 (Grass-Telefactor Divison, 2002) and 2 other predicates after a 267-day review. Its family tree reaches back 7 generations to 1988. 3 later devices descend from it.
- Decided
- Jul 20, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K875179 (1988). 48 ancestors in all, the oldest K791580 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 6 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 5 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 4 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 3 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 2 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 1 generation backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- This deviceK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · 2 generations on · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
- Descendant · cites it directly · 0 of its ownK190760 Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −6 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −5 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −4 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −3 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −2 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| 0 (this device) | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +1 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +2 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
| +1 | K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | 2019 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 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? (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 |
|---|---|---|---|
| * | K012976 | Twin PlusSummary page 4…r full-montage electroencephalograph Product code: OLZ (primary), OMB, OMA, OLT, ORT Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Twin Plus (K012976) primary; Moberg CNS (K080217); Natus SleepWorks (K090277) Description: 1. Overview NicoletOne Software The NicoletOne applic… | 2002 |
| * | K080217 | Component Neuromonitoring SystemSummary page 4…ograph Product code: OLZ (primary), OMB, OMA, OLT, ORT Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Twin Plus (K012976) primary; Moberg CNS (K080217); Natus SleepWorks (K090277) Description: 1. Overview NicoletOne Software The NicoletOne application is a software product fo… | 2008 |
| * | K090277 | Natus Sleepworks, Model 104017Summary page 4…rimary), OMB, OMA, OLT, ORT Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Twin Plus (K012976) primary; Moberg CNS (K080217); Natus SleepWorks (K090277) Description: 1. Overview NicoletOne Software The NicoletOne application is a software product for digital electroencephalogr… | 2011 |
What descends from it? (3)
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 30 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 10 of the 48 ancestors have a recall of any class.
- Of its descendants, K200878 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K012976.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
What is it indicated for?
The NicoletOne EEG/PSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders, sleep disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of…
Read the full statement (184 words)
The NicoletOne EEG/PSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders, sleep disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages.
NicoletOne software allows:
• Automated analysis of physiological signals that is intended for use only in adults.
• An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
• Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values.
This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173366: NicoletOne.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173366
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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