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 · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Mar 21, 2025 as substantially equivalent to K230933 (Epitel, Inc., 2023) after a 172-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Mar 21, 2025
- Review
- 172 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K830295 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 4 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 3 generations backK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- 2 generations backK203827 REMIEpitel, Inc. · 2021
- 1 generation backK230933 REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023
- This deviceK243185 REMI Remote EEG Monitoring SystemEpitel · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −4 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −3 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| −2 | K203827 | REMI | Epitel, Inc. | 2021 | — |
| −1 | K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230933 | REMI Remote EEG Monitoring SystemSummary page 5…400, GXY Sec. 882.1320 3. Predicate Devices Predicate Type 510(k) Number Name of Device Name of Manufacturer Primary Predicate K230933 REMI Remote EEG Epitel, Inc. Monitoring System 4. Devic… | 2023 |
| † | K182181 | Persyst 14 EEG Review and Analysis Software | 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 42 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 System 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. REMI System uses the REMI Mobile software application…
Read the full statement (161 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 System 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.
REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-
shelf mobile 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 System does not make any diagnostic conclusion about the subject's condition and is
intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric
patients (1+ years).
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/K243185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243185: 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/K243185
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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