510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830878Substantially Equivalent

Binocular Loupe

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

K830878 is the FDA 510(k) clearance record for BINOCULAR LOUPE, a class I device, cleared for Almore Intl., Inc. on under FDA product code HJH (Loupe, Binocular, Low Power). FDA records list 21 510(k) clearances for Almore Intl., Inc., from to . As of , FDA records show no recalls naming K830878.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HJH Loupe, Binocular, Low Power
Regulation
21 CFR 886.5120
Device class
Class I
Review panel
Ophthalmic
Applicant
Almore Intl., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HJH

Trailing 12 months

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

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