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Aok Tooling Limited

FDA Regulatory Profile

Aok Tooling Limited has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 23, 2017 · NAI
Latest 510(k)
Jul 27, 2022

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 23, 2017Shenzhen, ChinaDevicesNo Action Indicated (NAI)3006897516

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
K220876AOK 95A Medical Mask (20200049)Jul 27, 2022
K211956039 Surgical Face MaskNov 23, 2021
K201517Plain Surgical MaskSep 4, 2020

FDA data resources