510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930444Substantially Equivalent

Marco Standard Keratometers

Marco Ophthalmic, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930444 is the FDA 510(k) clearance record for MARCO STANDARD KERATOMETERS, a class I device, cleared for Marco Ophthalmic, Inc. on under FDA product code HJB (Instrument, Measuring, Corneal Radius). FDA records list 15 510(k) clearances for Marco Ophthalmic, Inc., from to . As of , FDA records show no recalls naming K930444.

Clearance record

Decision date
Received
(195 days to decision)
Product code
HJB Instrument, Measuring, Corneal Radius
Regulation
21 CFR 886.1450
Device class
Class I
Review panel
Ophthalmic
Applicant
Marco Ophthalmic, Inc. 11825 Central Pkwy., Jacksonville FL
510(k) summary
Statement
Third party review
No

Clearances, product code HJB

Trailing 12 months

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

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