510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253301Substantially Equivalent

BraiN20® (BraiN20)

Time IS Brain, S.L., Badalona, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253301 is the FDA 510(k) clearance record for BraiN20® (BraiN20), a class II device, cleared for Time IS Brain, S.L. on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list one 510(k) clearance for Time IS Brain, S.L. As of , FDA records show no recalls naming K253301.

Clearance record

Decision date
Received
(271 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Time IS Brain, S.L. Carretera De Canyet S/N, Badalona, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWF

Trailing 12 months
3 clearances under product code GWF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260