510(k) · Cleared
ClearedCNS Envision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moberg Research, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Dec 17, 2019 as substantially equivalent to K080217 (Moberg Research, Inc., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Dec 17, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OLT
- 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 deviceK192572 CNS EnvisionMoberg Research, Inc. · 2019
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) | K192572 | CNS Envision | Moberg Research, 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 | 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 |
| 2018 | 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? (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 5…S Envision Traditional 510(k) Summary Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A) Predicate Device: K080217 Component Neuromonitoring System (Primary Predicate) K182181 Persyst 14 EEG Review an… | 2008 |
| * | K182181 | Persyst 14 EEG Review and Analysis SoftwareSummary page 5…ional and Neurodiagnostic Devices (DHT5A) Predicate Device: K080217 Component Neuromonitoring System (Primary Predicate) K182181 Persyst 14 EEG Review and Analysis Software Device Description: CNS Envision is a Microsoft Windows-based software application… | 2018 |
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 31 years and passes through 6 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 OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
CNS Envision is intended for use by qualified personnel in the review, annotation, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score. CNS Envision includes the calculation and display of a set of quantitative measures…
Read the full statement (159 words)
CNS Envision is intended for use by qualified personnel in the review, annotation, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score.
CNS Envision includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveforms. These include, for example, frequency bands, asymmetry, and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
The aEEG functionality included in CNS Envision is intended to monitor the state of the brain.
CNS Envision is intended for use by a physician or other qualified medical personnel who will exercise professional judgement in using the information. It is intended for use on patients of all ages.
This device does not provide any diagnostic conclusion about the patient’s condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192572: CNS Envision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192572
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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