510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201989Substantially Equivalent

B4C System

Braincare Desenvolvimento e Inovacao Tecnologica S.A., São Carlos, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201989 is the FDA 510(k) clearance record for B4C System, a class II device, cleared for Braincare Desenvolvimento E Inovacao Tecnologica S.A. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 3 510(k) clearances for Braincare Desenvolvimento E Inovacao Tecnologica S.A., from to . As of , FDA records show no recalls naming K201989.

Clearance record

Decision date
Received
(448 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Braincare Desenvolvimento E Inovacao Tecnologica S.A. Avenida Bruno Ruggiero Filho, 971, São Carlos, BR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWM

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