Data / Medical devices / United States / Baylab Usa
Baylab Usa: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Baylab Usa is registered with the FDA (registration 3017517827) in Dallas, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 7, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017517827
- Address
- 2230 LBJ FREEWAY Suite 100, Dallas, TX, United States, 75234
- Owner or operator
- BayLab USA (10078379)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 20, 2020
- Registered through
- 2026
- Brand names listed
- BAYLAB USA Surgical Mask, BL3-50221, BL3-59941, BLK-39425, BLW-64926
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical, Eua Authorized | QMF | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2021 | K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I) | FXX | Substantially Equivalent | Baylab USA, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Mask, Surgical
Updated December 7, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.