Asahi ViE-U Series Dialyzer— 510(k) K162248

Name: FDA 510(k) clearance K162248
Creator: U.S. Food and Drug Administration
Published: 2017-05-03

Substantially Equivalent

Asahi Kasei Medical Co., Ltd.

FDA 510(k) clearance K162248 for Asahi ViE-U Series Dialyzer, Substantially Equivalent on 2017-05-03. Applicant: Asahi Kasei Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Asahi Kasei Medical Co., Ltd.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-10
Decision date: 2017-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDI

view all

K261267 — Careflux H60; Careflux H70; Careflux V5002026-07-24
K252377 — NxStage System One with NxView2026-05-15
K260533 — ELISIO-H2026-03-19
K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)2026-02-10
K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)2026-01-26

More clearances from Asahi Kasei Medical Co., Ltd.

view all

K153344 — Asahi REXEED-S Series Dialyzer2015-12-17
K121409 — ASAHI REXEED-SX/LX SERIES DIALYZER2013-02-06
K082515 — ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX2008-10-03
K051187 — REXEED SERIES DIALYZERS2005-06-08

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.