510(k) · Cleared
ClearediCEWav Neuromonitoring Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ice Neurosystems, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Mar 31, 2020 as substantially equivalent to K080217 (Moberg Research, Inc., 2008) and 1 other predicate after a 263-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Mar 31, 2020
- Review
- 263 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K875179 (1988). 46 ancestors in all, the oldest K791580 (1979). No later device cites it as a predicate yet.
- 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 deviceK191868 iCEWav Neuromonitoring PlatformIce Neurosystems, Inc. · 2020
View 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) | K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | 2020 | — |
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 | 2 | 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 | 2 | 0 |
| 2003 | 3 | 0 |
| 2015 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 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? (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 |
|---|---|---|---|
| * | K080217 | Component Neuromonitoring SystemSummary page 4…iCEWav Neuromonitoring Platform is being compared to the software applications in the predicate Component Neuromonitoring System, manufactured by Moberg Research, Inc. (K080217) and Persyst 13 manufactured by Persyst Development Corporation (K151929). The Moberg software application acquires, displays, st… | 2008 |
| * | K151929 | Persyst 13 (P13) Eeg Review and Analysis SoftwareSummary page 4…ations in the predicate Component Neuromonitoring System, manufactured by Moberg Research, Inc. (K080217) and Persyst 13 manufactured by Persyst Development Corporation (K151929). The Moberg software application acquires, displays, stores and archives electroencephalographic signals from the brain in addit… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 3.2 years on median.
- 9 of the 46 ancestors have a recall of any class.
- 4 other devices also cite its predicate K080217.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices.
The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191868: iCEWav Neuromonitoring Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191868
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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