510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863994Substantially Equivalent

Viewscan

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

K863994 is the FDA 510(k) clearance record for VIEWSCAN, a class I device, cleared for Sensory Aids Corp. on under FDA product code HOT (Aid, Vision Image Intensification). FDA records list 4 510(k) clearances for Sensory Aids Corp., from to . As of , FDA records show no recalls naming K863994.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HOT Aid, Vision Image Intensification
Regulation
21 CFR 886.5910
Device class
Class I
Review panel
Ophthalmic
Applicant
Sensory Aids Corp. 205 W. Grand Ave.,, Bensenville IL
Third party review
No

Clearances, product code HOT

Trailing 12 months

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

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