Data / Medical devices / United States / Aerobiotix Usa
Aerobiotix Usa: FDA-registered device maker in Miamisburg, OH, United States, 1 510(k) clearance
Aerobiotix Usa is registered with the FDA (registration 3014151865) in Miamisburg, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 21, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014151865
- Address
- 444 Alexandersville Rd, Miamisburg, OH, United States, 45342
- Owner or operator
- Aerobiotix USA (10094028)
- Roles
- Manufacturer
- First device listed
- September 19, 2025
- Registered through
- 2027
- Brand names listed
- AeroCure Vac, AeroCure Vac Filter Drape, AeroCure Vac HEPA Filter Assembly, AeroCure Vac Hose XL, AeroCure Vac Sterile Filter Drape, AeroCure-HUAIRS, Cartridge Assemble Performance Level 2, Cartridge Assembly RFID and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Air Handling, Room | FZH | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Purifier, Air, Ultraviolet, Medical | FRA | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 21, 2021 | K203189 | AEROCURE-MD | FRA | Substantially Equivalent | Aerobiotix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
- All makers of Apparatus, Air Handling, Room
- All makers of Purifier, Air, Ultraviolet, Medical
Updated January 21, 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.