510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854047Substantially Equivalent

In-Home Vision Monitoring Kit

Rich-Larky Company, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854047 is the FDA 510(k) clearance record for IN-HOME VISION MONITORING KIT, a class I device, cleared for Rich-Larky Company, Inc. on under FDA product code HOX (Chart, Visual Acuity). FDA records list one 510(k) clearance for Rich-Larky Company, Inc. As of , FDA records show no recalls naming K854047.

Clearance record

Decision date
Received
(71 days to decision)
Product code
HOX Chart, Visual Acuity
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Rich-Larky Company, Inc. 1029 Vermont Ave. #400, Washington DC
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