510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812764Substantially Equivalent

Koi Blue Field Entoptoscope

Koi, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812764 is the FDA 510(k) clearance record for KOI BLUE FIELD ENTOPTOSCOPE, a class II device, cleared for Koi, Inc. on under FDA product code HKL (Retinoscope, Ac-Powered). FDA records list 5 510(k) clearances for Koi, Inc., from to . As of , FDA records show no recalls naming K812764.

Clearance record

Decision date
Received
(61 days to decision)
Product code
HKL Retinoscope, Ac-Powered
Regulation
21 CFR 886.1780
Device class
Class II
Review panel
Ophthalmic
Applicant
Koi, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HKL

Trailing 12 months

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

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