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
K863995Substantially Equivalent

Keynote

Sensory Aids Corp., Bensenville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863995 is the FDA 510(k) clearance record for KEYNOTE, a class II device, cleared for Sensory Aids Corp. on under FDA product code ILQ (System, Communication, Powered). FDA records list 4 510(k) clearances for Sensory Aids Corp., from to . As of , FDA records show no recalls naming K863995.

Clearance record

Decision date
Received
(30 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Sensory Aids Corp. 205 W. Grand Ave.,, Bensenville IL
Third party review
No

Clearances, product code ILQ

Trailing 12 months

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

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