510(k) · Cleared
ClearedHippoMind (v1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hippoclinic · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Dec 3, 2025 as substantially equivalent to K200878 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2020) and 2 other predicates after a 168-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Dec 3, 2025
- Review
- 168 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K875179 (1988). 58 ancestors in all, the oldest K791580 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 5 generations between
- 3 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 2 generations backK173366 NicoletOneNatus Neurology Incorporated · 2018
- 1 generation backK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- This deviceK251881 HippoMind (v1.0)Hippoclinic · 2025
Show all 9 generations
- Root · 9 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 8 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 7 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 6 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 5 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 4 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 3 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 2 generations backK173366 NicoletOneNatus Neurology Incorporated · 2018
- 1 generation backK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- This deviceK251881 HippoMind (v1.0)Hippoclinic · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −8 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −7 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −6 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −5 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −4 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −3 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| −1 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| 0 (this device) | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
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 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K200878 | Natus NeuroWorksSummary page 5…ct Code(s) OLT, OMA, LLZ, OLY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200878 Natus Neuroworks OLT K172490 eUnity LLZz K030737 CTF Whole-Cortex MEG System OLY Device Description Summary 21 CFR 807.92(a)(4)… | 2020 |
| * | K172490 | eUnitySummary page 5…| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200878 Natus Neuroworks OLT K172490 eUnity LLZz K030737 CTF Whole-Cortex MEG System OLY Device Description Summary 21 CFR 807.92(a)(4) clinical decision-making. Hi… | 2018 |
| * | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Summary page 5…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200878 Natus Neuroworks OLT K172490 eUnity LLZz K030737 CTF Whole-Cortex MEG System OLY Device Description Summary 21 CFR 807.92(a)(4) clinical decision-making. HippoMind is a cloud-b… | 2003 |
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 37 years and passes through 9 companies; a new generation was cleared every 3.2 years on median.
- 11 of the 58 ancestors have a recall of any class.
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. 2025, 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?
HippoMind is a software application that displays neuroimaging and neurosignaling data for review by a health care provider. It provides simple tools for analysis of both medical images and EEG/MEG data. It also allows for storage and transfer of data, and association of data with electronic health records. It is intended for use by qualified health care professionals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251881: HippoMind (v1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251881
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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