De Novo · Granted
GrantedMinder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epi-Minder Pty, Ltd. · SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Granted on Apr 17, 2025 as a new device type through De Novo after a 181-day review. 1 later device descends from it.
- Decided
- Apr 17, 2025
- Review
- 181 days
- Class
- Class II
- Product code
- SEM
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN240062 Minder SystemEpi-Minder Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253607 UNEEG EpiSight SystemUneeg Medical A/S · 2026
Most influential descendants
Showing 1 of 1 · See all- K253607UNEEG EpiSight SystemUneeg Medical A/S · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240062 | Minder System | Epi-Minder Pty, Ltd. | 2025 | — |
| +1 | K253607 | UNEEG EpiSight System | Uneeg Medical A/S | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 SEM? 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 SEM device
- #1 K253607 UNEEG EpiSight Systemscore 11.5 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253607 | UNEEG EpiSight System | 2026 | 0 |
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?
- Of its descendants, K253607 (Uneeg Medical A/S, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SEM devicesSEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SEM
Too few SEM 510(k)s in any year since 2007 to give a median.
Recalls per year · SEM
No recall names SEM since 2007.
Adverse event reports per year · SEM
No MAUDE report names SEM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Minder System is an electroencephalographic (EEG) recording and transmitting device implanted under the scalp. It is a prescription device indicated to acquire, transmit, and store EEGs continuously from patients between 18-75 years of age with drug-resistant epilepsy who are intolerant or not indicated for more conservative monitoring tools. The Minder System is intended to aid in a physician's remote assessment and monitoring of the indicated…
Read the full statement (144 words)
The Minder System is an electroencephalographic (EEG) recording and transmitting device implanted under the scalp. It is a prescription device indicated to acquire, transmit, and store EEGs continuously from patients between 18-75 years of age with drug-resistant epilepsy who are intolerant or not indicated for more conservative monitoring tools. The Minder System is intended to aid in a physician's remote assessment and monitoring of the indicated patient’s condition. Remote patient assessment and monitoring for this use is defined as the patient’s EEG data is available for review by a healthcare provider located at a different location from the patient and where the data is being collected.
The medical use of the data acquired by the Minder System is to be performed under the direction and interpretation of a licensed medical professional. The Minder System does not provide any diagnostic conclusions about the patient's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240062 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240062: Minder System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240062
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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