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Baylab USA, LLC

FDA Regulatory Profile

Baylab USA, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 1 compliance action on record.

Latest inspection
May 20, 2025 · OAI
Latest 510(k)
Dec 7, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 20, 2025Dallas, TXDevicesOfficial Action Indicated (OAI)3017517827
Jan 31, 2024Dallas, TXDevicesOfficial Action Indicated (OAI)3017517827

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
K212302BAYLAB 3-Ply Surgical Mask (BEACON I)Dec 7, 2021

FDA data resources