510(k) · Cleared
ClearedUNEEG EpiSight System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uneeg Medical A/S · SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Cleared on Jun 11, 2026 as substantially equivalent to DEN240062 (Epi-Minder Pty, Ltd., 2025) after a 205-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Jun 11, 2026
- Review
- 205 days
- Class
- Class II
- Product code
- SEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240062 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240062 Minder SystemEpi-Minder Pty, Ltd. · 2025
- This deviceK253607 UNEEG EpiSight SystemUneeg Medical A/S · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240062 | Minder System | Epi-Minder Pty, Ltd. | 2025 | — |
| 0 (this device) | K253607 | UNEEG EpiSight System | Uneeg Medical A/S | 2026 | — |
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 SEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN240062 | Minder SystemSummary page 5…882.1360 Product Code(s): SEM Legally Marketed Predicate Devices (21 CFR 807.92(a)(3) Predicate # Predicate Trade Name Product Code DEN240062 Minder System SEM Device Description Summary (21 CFR 807.92(a)(4) The UNEEG EpiSight System is an… | 2025 |
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?
- Its one ancestor has no recall.
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. 2026, 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 UNEEG EpiSight System is an electroencephalographic (EEG) recording and transmitting device system with a subcutaneous implant. It is indicated for continuous EEG recording in patients aged 18 and older with uncontrolled epilepsy. The UNEEG EpiSight System is a prescription device intended to aid in physician’s remote assessment and monitoring of the patient’s condition. Remote assessment and monitoring are defined as the availability of EEG data for…
Read the full statement (121 words)
The UNEEG EpiSight System is an electroencephalographic (EEG) recording and transmitting device system with a subcutaneous implant. It is indicated for continuous EEG recording in patients aged 18 and older with uncontrolled epilepsy.
The UNEEG EpiSight System is a prescription device intended to aid in physician’s remote assessment and monitoring of the patient’s condition. Remote assessment and monitoring are defined as the availability of EEG data for review by a healthcare provider located at a different location from where the data is being collected.
The medical use of the data acquired by the UNEEG EpiSight System is to be performed under the direction and interpretation of a licensed medical professional. The device does not provide diagnostic conclusions regarding the patient’s condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253607: UNEEG EpiSight System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253607
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026