510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881971Substantially Equivalent

Occu-Tech Vision Test

Applied Vision Concepts, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881971 is the FDA 510(k) clearance record for OCCU-TECH VISION TEST, a class I device, cleared for Applied Vision Concepts, Inc. on under FDA product code HOX (Chart, Visual Acuity). FDA records list one 510(k) clearance for Applied Vision Concepts, Inc. As of , FDA records show no recalls naming K881971.

Clearance record

Decision date
Received
(198 days to decision)
Product code
HOX Chart, Visual Acuity
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Applied Vision Concepts, Inc. 9898 SW Lynnwood Terr., Portland OR
Third party review
No

Clearances, product code HOX

Trailing 12 months

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

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