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Biowy Corporation

FDA Regulatory Profile

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

Latest inspection
Aug 8, 2025 · NAI
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) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 8, 2025Lake Forest, CABiologicsNo Action Indicated (NAI)3013233645
Nov 8, 2019Lake Forest, CADevicesNo Action Indicated (NAI)3013233645

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 3013233645Lake Forest, CA2Aug 8, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K233658Biowy Tym Tube (TT)Feb 16, 2024
K192246Biowy PICC Catheter S KitApr 30, 2020
K173956Biowy PlCC CatheterMay 21, 2018

FDA data resources

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