Data / Medical devices / United States / Biotab LLC
Biotab LLC: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Biotab LLC is registered with the FDA (registration 3024685280) in Saint Louis, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024685280
- Address
- 11701 Borman Dr Suite 107, Saint Louis, MO, United States, 63146
- Owner or operator
- BioTAB LLC (10086712)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 16, 2025
- Registered through
- 2026
- Brand names listed
- PnueAira
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 18, 2025 | K251086 | PnueAira (PNCU-01) | JOW | Substantially Equivalent | Biotab, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 18, 2025. 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.