Data / Medical devices / United States / Pneo, LLC
Pneo, LLC: FDA-registered device maker in Denton, TX, United States, 1 510(k) clearance
Pneo, LLC is registered with the FDA (registration 3011418975) in Denton, TX, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 12, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011418975
- Address
- 204 Cardinal Drive, Denton, TX, United States, 76209
- Owner or operator
- pNeo, LLC (10048567)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 27, 2015
- Registered through
- 2026
- Brand names listed
- Oto-Tip, Shusher Care, Shusher Care Atomizer, Shusher Care Atomizing Nebulizer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Ent | KCJ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | 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 |
|---|---|---|---|---|---|---|
| November 12, 2008 | K082762 | AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE | JCX | Substantially Equivalent | Aardvark Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Ent
- All makers of Irrigator, Sinus
- All makers of Nasal Spray, Ent Delivery
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Fiber, Medical, Absorbent
Updated November 12, 2008. 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.