510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122952Substantially Equivalent

Nipro Pureflux-L Hemodialyzer

Nipro Medical Corporation, Suwanee GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122952 is the FDA 510(k) clearance record for NIPRO PUREFLUX-L HEMODIALYZER, a class II device, cleared for Nipro Medical Corporation on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 62 510(k) clearances for Nipro Medical Corporation, from to . As of , FDA records show no recalls naming K122952.

Clearance record

Decision date
Received
(435 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nipro Medical Corporation 6695 River Crest Pt., Suwanee GA
510(k) summary
Summary PDF
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