510(k) · Cleared
ClearedREMI
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 Mar 29, 2021 as substantially equivalent to K171459 (Ceribell, Inc., 2017) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1983. 3 later devices descend from it.
- Decided
- Mar 29, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K830295 (1983). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 2 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 1 generation backK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- This deviceK203827 REMIEpitel, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230933 REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243185 REMI Remote EEG Monitoring SystemEpitel · 2025
- Descendant · cites it directly · 0 of its ownK223628 NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −2 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −1 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| 0 (this device) | K203827 | REMI | Epitel, Inc. | 2021 | — |
| +1 | K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023 | — |
| +2 | K243185 | REMI Remote EEG Monitoring System | Epitel | 2025 | — |
| +1 | K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | 2023 | — |
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 |
|---|---|---|
| 2023 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K171459 | Ceribell Instant EEG HeadbandSummary page 5…Traditional-51 0(k) Submission Predicate Type 510(k) Number Name Of Device Name Of Manufacturer Predicate Device K171459 Ceribell Instant EEG Headband Ceribell, Inc. Predicate Device K170363 Ceribell Pock… | 2017 |
| * | K170363 | Ceribell Pocket EEG DeviceSummary page 5…Name Of Manufacturer Predicate Device K171459 Ceribell Instant EEG Headband Ceribell, Inc. Predicate Device K170363 Ceribell Pocket EEG Device Ceribell, Inc. Predicate Device Kl83529 AE-120A EEG H… | 2017 |
| * | K183529 | AE-120A EEG Head SetSummary page 7…AE-120A EEG Head Set Life Sensor Cardiac Monitor (K183529) (K191331) *Both K170363 and K171459… | 2019 |
| † | K191331 | Life Sensor Cardiac Monitor | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 38 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K230933 (Epitel, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K171459.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors — a single use, single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to…
Read the full statement (132 words)
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted.
REMI consists of Epilog disposable Sensors — a single use, single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software.
REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
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/K203827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203827: REMI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203827
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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