510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942926Substantially Equivalent

Neuro-Aide

Burke Neutech, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942926 is the FDA 510(k) clearance record for NEURO-AIDE, a class I device, cleared for Burke Neutech, Inc. on under FDA product code GWY (Pinwheel). FDA records list 7 510(k) clearances for Burke Neutech, Inc., from to . As of , FDA records show no recalls naming K942926.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GWY Pinwheel
Regulation
21 CFR 882.1750
Device class
Class I
Review panel
Neurology
Applicant
Burke Neutech, Inc. 11701 S. Belcher Rd.,, Largo FL
510(k) summary
Statement
Third party review
No

Clearances, product code GWY

Trailing 12 months

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

FDA records show no clearances under product code GWY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWY, 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