510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991512Substantially Equivalent

Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-X

Asahi Kasei Medical MT Corp. Oita Works, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991512 is the FDA 510(k) clearance record for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X, a class II device, cleared for Asahi Medical Co., Ltd. on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 16 510(k) clearances for Asahi Kasei Medical MT Corp. Oita Works, from to . As of , FDA records show one recall naming K991512.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Asahi Medical Co., Ltd. 15825 Shady Grove Rd.,, Rockville MD
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