510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K800001Substantially Equivalent

Mini-Cears Computer (Model 1)

Bik Foundation, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800001 is the FDA 510(k) clearance record for MINI-CEARS COMPUTER (MODEL 1), a class I device, cleared for Bik Foundation, Inc. on under FDA product code GWS (Analyzer, Spectrum, Electroencephalogram Signal). FDA records list one 510(k) clearance for Bik Foundation, Inc. As of , FDA records show no recalls naming K800001.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GWS Analyzer, Spectrum, Electroencephalogram Signal
Regulation
21 CFR 882.1420
Device class
Class I
Review panel
Neurology
Applicant
Bik Foundation, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GWS

Trailing 12 months

FDA records hold no clearances under product code GWS in the trailing twelve months.

FDA records show no clearances under product code GWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260