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Asahi Kasei Medical Co., Ltd.

FDA Regulatory Profile

Asahi Kasei Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 9, 2015 · NAI
Latest 510(k)
May 3, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 9, 2015Chiyoda, JapanDevicesNo Action Indicated (NAI)3009960884

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K162248Asahi ViE-U Series DialyzerMay 3, 2017
K153344Asahi REXEED-S Series DialyzerDec 17, 2015
K121409ASAHI REXEED-SX/LX SERIES DIALYZERFeb 6, 2013
K082515ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXOct 3, 2008
K051187REXEED SERIES DIALYZERSJun 8, 2005

FDA data resources