510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231804Substantially Equivalent

PRIME-XV FreezIS DMSO-Free MD

FUJIFILM Biosciences Inc., Santa Ana CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231804 is the FDA 510(k) clearance record for PRIME-XV FreezIS DMSO-Free MD, a class II device, cleared for Fujifilm Irvine Scientific on under FDA product code NDS (Media, Culture, Ex Vivo, Tissue And Cell). FDA records list 45 510(k) clearances for FUJIFILM Biosciences INC., from to . As of , FDA records show no recalls naming K231804.

Clearance record

Decision date
Received
(142 days to decision)
Product code
NDS Media, Culture, Ex Vivo, Tissue And Cell
Regulation
21 CFR 876.5885
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujifilm Irvine Scientific 1830 E. Warner Ave., Santa Ana CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDS

Trailing 12 months

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

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