510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930503Substantially Equivalent

Clirans Wet Pack Hollow Fiber Dialyzer

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930503 is the FDA 510(k) clearance record for CLIRANS WET PACK HOLLOW FIBER DIALYZER, a class II device, cleared for Terumo Medical Corp. on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K930503.

Clearance record

Decision date
Received
(763 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Terumo Medical Corp. P.O. Box 605, Elkton MD
510(k) summary
Statement
Third party review
No

Clearances, product code FJI

Trailing 12 months

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

FDA records show no clearances under product code FJI in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260