510(k) · Cleared
ClearedSignalNED System (Model RE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forest Devices, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Sep 4, 2024 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Sep 4, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K964280 (1997). 6 ancestors in all, the oldest K830295 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964280 DG NervusMedelec, Ltd. · 1997 · Recalled
- 1 generation backK143487 Lifelines iEEGKvikna Ehf · 2015
- This deviceK242306 SignalNED System (Model RE)Forest Devices, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251726 SignalNED System (Model RE)Forest Devices, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251726SignalNED System (Model RE)Forest Devices, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964280 | DG Nervus | Medelec, Ltd. | 1997 | 1 |
| −1 | K143487 | Lifelines iEEG | Kvikna Ehf | 2015 | — |
| 0 (this device) | K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024 | — |
| +1 | K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K170363 | Ceribell Pocket EEG DeviceSummary page 5…Trade Name Predicate Product Code (Primary Predicate is listed first) K170363 Ceribell Pocket EEG Device OMC, Reduced-Montage Standard Electroencephalograph (Primary) K143487 Lifeline… | 2017 |
| * | K143487 | Lifelines iEEGSummary page 5…(Primary Predicate is listed first) K170363 Ceribell Pocket EEG Device OMC, Reduced-Montage Standard Electroencephalograph (Primary) K143487 Lifelines iEEG 2.0 OLT, Non-Normalizing Quantitative Electroencephalograph Software (Secondary) K1714… | 2015 |
| * | K171459 | Ceribell Instant EEG HeadbandSummary page 5…Electroencephalograph (Primary) K143487 Lifelines iEEG 2.0 OLT, Non-Normalizing Quantitative Electroencephalograph Software (Secondary) K171459 Ceribell Instant EEG Headband GXY, Cutaneous Electrode (Secondary) Device Description Summary The SignalNED Model RE… | 2017 |
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 |
|---|---|---|---|
| K251726 | SignalNED System (Model RE) | 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 18.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K251726 (Forest Devices, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K170363.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SignalNED Device is intended to record and store EEG signals and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the user analyze the EEG. The SignalNED does not provide any diagnostic conclusion about the patient’s condition. The device is intended to be used on adults by qualified medical and clinical professionals.
The SignalNED is intended to be used in a professional healthcare environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242306: SignalNED System (Model RE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242306
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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