Asahi Rexeed-Sx/Lx Dialyzers, Models: 13sx, 15sx, 18sx, 21sx, 25sx, 13lx, 15lx,…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K082515

Identifiers

510(k) Number: K082515 FDA 510(k)
FDA Product Code: KDI FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.5860 FDA 510(k)
Regulation Number: 876.5860 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Asahi Rexeed-Sx/Lx Dialyzers, Models: 13sx, 15sx, 18sx, 21sx, 25sx, 13lx, 15lx,… by Asahi Kasei Medical Co., Ltd. — Class II — MDD, MDR, FDA_510K — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K082515	Class II	Active

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Manufacturer

Manufacturer: Asahi Kasei Medical Co., Ltd.

Sources (2)

FDA 510(k) K082515 24 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced May 19, 2026