510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821080Substantially Equivalent

Hand Keratoscope

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

K821080 is the FDA 510(k) clearance record for HAND KERATOSCOPE, a class I device, cleared for Medical Equipment Designs, Inc. on under FDA product code HLR (Keratoscope, Battery-Powered). FDA records list 13 510(k) clearances for Medical Equipment Designs, Inc., from to . As of , FDA records show no recalls naming K821080.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HLR Keratoscope, Battery-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Medical Equipment Designs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HLR

Trailing 12 months

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

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