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KANEKA Corporation

FDA Regulatory Profile

KANEKA Corporation has 0 FDA recalls, 7 inspections, 11 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 6, 2025 · VAI
Latest 510(k)
Mar 19, 2018

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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) clearances11Oct 4, 2026Not statedCurrent
Inspections7Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 6, 2025Settsu, JapanDevicesVoluntary Action Indicated (VAI)3002808904
Oct 13, 2023Takasago-Cho, JapanDrugsVoluntary Action Indicated (VAI)3002807368
Apr 19, 2017Settsu, JapanDevicesNo Action Indicated (NAI)3002808904
Mar 3, 2016Settsu, JapanDevicesNo Action Indicated (NAI)3002808904
Nov 16, 2012Takasago-Cho, JapanFood/CosmeticsNo Action Indicated (NAI)3002807368
Sep 13, 2012Settsu, JapanDevicesNo Action Indicated (NAI)3002808904
Jun 3, 2010Takasago-Cho, JapanDrugsNo Action Indicated (NAI)3002807368

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
K172264OTW Takeru PTCA Balloon Dilatation CatheterMar 19, 2018
K170941RX NC Takeru PTCA Balloon Dilatation CatheterJul 7, 2017
K163372RX Takeru Balloon Dilatation CatheterApr 7, 2017
K163479R2P Metacross RXJan 11, 2017
K160013Crosperio OTWApr 29, 2016
K160004Crosstella OTWApr 29, 2016
K152873Crosstella RX Balloon Dilatation CatheterJan 22, 2016
K152887Crosperio RX PTA Balloon Dilatation CatheterJan 22, 2016
K152080Metacross OTW PTA Balloon Dilatation CatheterSep 24, 2015
K150865Metacross RX PTA Balloon Dilitation CatheterAug 3, 2015
K102999TRIMOTION INJECTORDec 29, 2011

FDA data resources