510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881165Substantially Equivalent

Sakura Hem-480 Electron Microscopy Processor

Sakura Finetek USA Inc, Torrance CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881165 is the FDA 510(k) clearance record for SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR, a class I device, cleared for Sakura Finetek U.S.A., Inc. on under FDA product code IEO (Processor, Tissue, Automated). FDA records list 4 510(k) clearances for Sakura Finetek U.S.A., Inc., from to . As of , FDA records show no recalls naming K881165.

Clearance record

Decision date
Received
(103 days to decision)
Product code
IEO Processor, Tissue, Automated
Regulation
21 CFR 864.3875
Device class
Class I
Review panel
Pathology
Applicant
Sakura Finetek U.S.A., Inc. 23440 Hawthorne Blvd., Torrance CA
Third party review
No

Clearances, product code IEO

Trailing 12 months

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

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