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 3, 2025 as substantially equivalent to K242306 (Forest Devices, Inc., 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Sep 3, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K801604 (1980). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 3 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 2 generations backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- 1 generation backK171414 qEEG-ProBrainmaster Technologies, Inc. · 2018
- This deviceK251726 SignalNED System (Model RE)Forest Devices, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −3 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −2 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| −1 | K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018 | — |
| 0 (this device) | 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 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K242306 | SignalNED System (Model RE)Summary page 5…Y (Electrode, Cutaneous), and OLU (Normalizing Quantitative Electroencephalograph Software) Primary Predicate Device K Number: K242306 Device Trade Name: SignalNED System (Model RE) Common Name: Electroencephalograph Classification Name: R… | 2024 |
| * | K171414 | qEEG-ProSummary page 5…-Normalizing Quantitative Electroencephalograph Software), and GXY (Electrode, Cutaneous) Secondary Predicate Device K Number: K171414 Device Trade Name: BrainMaster Technologies, Inc. qEEG-Pro Common Name: Electroencephalograph Classification… | 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 45 years and passes through 5 companies; a new generation was cleared every 13.9 years on median.
- 1 of the 24 ancestors has a recall of any class.
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 SignalNED Device is intended to record and store EEG signals for the statistical evaluation of the human electroencephalogram (EEG) and display Quantitative EEG (qEEG) measures intended to help the user analyze the EEG. These measures include relative band power (e.g., alpha, beta, delta, theta) and band power asymmetry (displayed as a z-score compared to a normative database). 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251726: 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/K251726
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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