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Clearflow, Inc.

FDA Regulatory Profile

Clearflow, Inc. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 17, 2014 · NAI
Latest 510(k)
Mar 2, 2021

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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) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 17, 2014Irvine, CADevicesNo Action Indicated (NAI)3008782989

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
K203394PleuraFlow System with FlowGlideMar 2, 2021
K191733The ZIP Accessory Shuttle for PleuraFlow SystemJul 26, 2019
K182067PleuraFlow System with FlowGlide Extra Drainage LengthAug 14, 2018
K163139PleuraFlow System with FlowGlideNov 30, 2016
K153681PleuraFlow SystemJan 20, 2016
K150042PleuraFlow SystemJun 2, 2015

FDA data resources