Airgle Corporation

FDA Regulatory Profile

Airgle Corporation has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jun 30, 2026 · VAI
Latest 510(k)
Feb 16, 2024

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 30, 2026Holbrook, NYDevicesVoluntary Action Indicated (VAI)3030650766

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3030650766Holbrook, NY1Jun 30, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K232645Airgle Room Air PurifierFeb 16, 2024

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.