BraiN20® (BraiN20)— 510(k) K253301

Name: FDA 510(k) clearance K253301
Creator: U.S. Food and Drug Administration
Published: 2026-06-27

Substantially Equivalent

Time IS Brain, S.L.

FDA 510(k) clearance K253301 for BraiN20® (BraiN20), Substantially Equivalent on 2026-06-27. Applicant: Time IS Brain, S.L.. Device class: 2.

Summary

BraiN20 from Time IS Brain is filed under GWF, evoked response electrical stimulators. The record doesn't describe the device beyond its name and the code name.

Class II, 21 CFR 882.1870. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Time IS Brain filed from Badalona, Spain. Review took 271 calendar days (September 29, 2025 to June 27, 2026).

Clearance details

Applicant: Time IS Brain, S.L.
Product code: Product code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 2025-09-29
Decision date: 2026-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Badalona, ES

Download summary PDF View on FDA.gov ↗

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K242345 — Delphi Stimulator2024-11-05

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.