510(k) · Cleared
ClearedREMI Remote EEG Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epitel, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Jun 30, 2023 as substantially equivalent to K203827 (Epitel, Inc., 2021) after an 88-day review. Its family tree reaches back 4 generations to 1983. 1 later device descends from it.
- Decided
- Jun 30, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830295 (1983). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 3 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 2 generations backK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- 1 generation backK203827 REMIEpitel, Inc. · 2021
- This deviceK230933 REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243185 REMI Remote EEG Monitoring SystemEpitel · 2025
Most influential descendants
Showing 1 of 1 · See all- K243185REMI Remote EEG Monitoring SystemEpitel · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −3 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −2 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| −1 | K203827 | REMI | Epitel, Inc. | 2021 | — |
| 0 (this device) | K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023 | — |
| +1 | K243185 | REMI Remote EEG Monitoring System | Epitel | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 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? (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 |
|---|---|---|---|
| * | K203827 | REMISummary page 4…ss: Class II Product Code and Regulation Number: OMC - Sec. 882.1400, GXY Sec. 882.1320 3. Predicate Device Name of Device: REMI 510(k) Number: K203827 Manufacturer: Epitel, Inc 4. Device Description REMI Sensors amplify electroencephalographic activity acquired from… | 2021 |
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 |
|---|---|---|---|
| K243185 | REMI Remote EEG Monitoring System | 2025 | 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?
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days. The REMI System uses the REMI-Mobile software application that…
Read the full statement (156 words)
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
The REMI System uses the REMI-Mobile software application that runs on qualified portable general purpose computing platforms. REMI-Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI-Mobile receives and transmits data from connected REMI Sensors to the secure REMI-Cloud where it is stored and prepared for review on qualified EEG viewing software.
REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230933: REMI Remote EEG Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230933
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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