Fudakang Industrial Co., Ltd.

FDA Regulatory Profile

Fudakang Industrial Co., Ltd. has 0 FDA recalls, 4 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 12, 2026 · VAI
Latest 510(k)
Jun 7, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 12, 2026Dongguan, ChinaDevicesVoluntary Action Indicated (VAI)3008167616
Oct 19, 2023Dongguan, ChinaDevicesNo Action Indicated (NAI)3008167616
Aug 25, 2016Las Vegas, NVDevicesNo Action Indicated (NAI)3008581794
Aug 7, 2014Dongguan, ChinaDevicesNo Action Indicated (NAI)3008167616

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
K172121Digital ThermometerJun 7, 2018
K160308Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)Jul 15, 2016
K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorApr 17, 2015
K111703INFRARED EAR THEROMETERMar 29, 2012