510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821084Substantially Equivalent

Universal Trial Framee

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

K821084 is the FDA 510(k) clearance record for UNIVERSAL TRIAL FRAMEE, a class I device, cleared for Medical Equipment Designs, Inc. on under FDA product code HPA (Frame, Trial, Ophthalmic). FDA records list 13 510(k) clearances for Medical Equipment Designs, Inc., from to . As of , FDA records show no recalls naming K821084.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HPA Frame, Trial, Ophthalmic
Regulation
21 CFR 886.1415
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 HPA

Trailing 12 months

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

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