510(k) · Cleared
ClearedBraiN20® (BraiN20)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Time IS Brain, S.L. · GWF Stimulator, Electrical, Evoked Response
Cleared on Jun 27, 2026 as substantially equivalent to K132616 (Safeop Surgical, Inc., 2014) and 1 other predicate after a 271-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 27, 2026
- Review
- 271 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K934426 (1994). 8 ancestors in all, the oldest K890495 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- 4 generations backK982595 NIM4Xomed, Inc. · 1998
- 3 generations backK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- 2 generations backK123843 Neuroepg SystemStrohl Medical Technologies · 2013
- 1 generation backK132616 EPADSafeop Surgical, Inc. · 2014
- This deviceK253301 BraiN20® (BraiN20)Time IS Brain, S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| −4 | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| −3 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| −2 | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
| −1 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
| 0 (this device) | K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 2010 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 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 |
|---|---|---|---|
| * | K132616 | EPADSummary page 5…or Regulation Number: 21 CFR 882.1870 Product Code: GWF Device Class: Class II PREDICATE DEVICES Primary Predicate Device: • EPAD Device (K132616) Secondary Predicate Device: • NeuroEPG System (K123843) PRIMARY PREDIC… | 2014 |
| * | K123843 | Neuroepg SystemSummary page 5…: Class II PREDICATE DEVICES Primary Predicate Device: • EPAD Device (K132616) Secondary Predicate Device: • NeuroEPG System (K123843) PRIMARY PREDICATE ADDITIONAL PREDICATE SUBJECT DEVICE… | 2013 |
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 32 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K132616.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The BraiN20® is intended for use in monitoring neurological status by recording the N20 response of somatosensory evoked potentials (SEP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253301: BraiN20® (BraiN20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253301
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026