510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K821170Substantially Equivalent

Cornea Perservation Unit

Xytex Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821170 is the FDA 510(k) clearance record for CORNEA PERSERVATION UNIT, cleared for Xytex Corp. on under FDA product code LYX (Media, Corneal Storage). FDA records list one 510(k) clearance for Xytex Corp. As of , FDA records show no recalls naming K821170.

Clearance record

Decision date
Received
(79 days to decision)
Product code
LYX Media, Corneal Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Xytex Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LYX

Trailing 12 months

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

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