510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830774Substantially Equivalent

Binocular Magnifier 2X

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

K830774 is the FDA 510(k) clearance record for BINOCULAR MAGNIFIER 2X, a class I device, cleared for Almore Intl., Inc. on under FDA product code HKC (Spectacle Microscope, Low-Vision). FDA records list 21 510(k) clearances for Almore Intl., Inc., from to . As of , FDA records show no recalls naming K830774.

Clearance record

Decision date
Received
(26 days to decision)
Product code
HKC Spectacle Microscope, Low-Vision
Regulation
21 CFR 886.5540
Device class
Class I
Review panel
Ophthalmic
Applicant
Almore Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HKC

Trailing 12 months

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

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