510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830430Substantially Equivalent

Eyelid Speculum

Douglas C. Mckee & Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830430 is the FDA 510(k) clearance record for EYELID SPECULUM, a class I device, cleared for Douglas C. Mckee & Co. on under FDA product code HNC (Specula, Ophthalmic). FDA records list one 510(k) clearance for Douglas C. Mckee & Co. As of , FDA records show no recalls naming K830430.

Clearance record

Decision date
Received
(121 days to decision)
Product code
HNC Specula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Douglas C. Mckee & Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HNC

Trailing 12 months

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

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