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O2 Concepts, LLC

FDA Regulatory Profile

O2 Concepts, LLC has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jan 11, 2024 · NAI
Latest 510(k)
Dec 20, 2018

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 11, 2024Middlebury, CTDevicesNo Action Indicated (NAI)3008910673
Jan 10, 2018Middlebury, CTDevicesVoluntary Action Indicated (VAI)3008910673
Dec 6, 2013Newtown, CTDevicesVoluntary Action Indicated (VAI)3009733718

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
K182454O2 Concepts Oxlife Independence Model 301-0001Dec 20, 2018

FDA data resources