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Orantech, Inc.

FDA Regulatory Profile

Orantech, Inc. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 1, 2024 · NAI
Latest 510(k)
Jan 30, 2019

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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 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 1, 2024Shenzhen, ChinaDevicesNo Action Indicated (NAI)3013783488

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
K182327Patient Cables and Leadwires , Disposable ECG LeadwiresJan 30, 2019
K173194Temperature ProbeOct 10, 2018
K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsSep 7, 2018
K173197Reusable NIBP CuffAug 21, 2018
K171828ETCO2 SensorMay 31, 2018

FDA data resources