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Airxpanders, Inc.

FDA Regulatory Profile

Airxpanders, Inc. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 16, 2015 · VAI
Latest 510(k)
Jul 11, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 16, 2015Palo Alto, CADevicesVoluntary Action Indicated (VAI)3009130440
Apr 16, 2014Palo Alto, CADevicesNo Action Indicated (NAI)3009130440

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
K191138AeroForm Tissue Expander, SmoothJul 11, 2019
K170075AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Apr 3, 2017
DEN150055AeroForm Tissue Expander SystemDec 21, 2016

FDA data resources