510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945631Substantially Equivalent

155 Sce(tm) Hemodialyzer

Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945631 is the FDA 510(k) clearance record for 155 SCE(TM) HEMODIALYZER, a class II device, cleared for Althin Medical AB an Affiliate of Baxter Intl on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 27 510(k) clearances for Althin Medical AB an Affiliate of Baxter Intl, from to . As of , FDA records show no recalls naming K945631.

Clearance record

Decision date
Received
(183 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Althin Medical AB an Affiliate of Baxter Intl 14620 NW 60th Ave., Miami Lakes FL
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJI, 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