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.

Clearance details

Applicant: Time IS Brain, S.L.
Product code: 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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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.