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Inova Labs, Inc.

FDA Regulatory Profile

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

Latest inspection
Oct 27, 2022 · NAI
Latest 510(k)
Apr 3, 2020

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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 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 27, 2022San Diego, CADevicesNo Action Indicated (NAI)3016721280
Dec 15, 2016Austin, TXDevicesNo Action Indicated (NAI)3008185181

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
K200564Aria SystemApr 3, 2020
K132205ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEMJun 6, 2014
K113317LIFECHOICE OXYGEN CONCENTRATORDec 28, 2011

FDA data resources