510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893829Substantially Equivalent

Powered Eye Wash

Sacks Model Makers, Ringwood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893829 is the FDA 510(k) clearance record for POWERED EYE WASH, a class III device, cleared for Sacks Model Makers on under FDA product code MSI (Solution, Cleaning / Lubricating, Artificial Eye). FDA records list one 510(k) clearance for Sacks Model Makers. As of , FDA records show no recalls naming K893829.

Clearance record

Decision date
Received
(174 days to decision)
Product code
MSI Solution, Cleaning / Lubricating, Artificial Eye
Device class
Class III
Review panel
Unknown
Applicant
Sacks Model Makers 509 Skyline Lks. Dr., Ringwood NJ
Third party review
No

Clearances, product code MSI

Trailing 12 months

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

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