Data / Medical devices / United States / Rhinosystems, Inc.
Rhinosystems, Inc.: FDA-registered device maker in Brooklyn, OH, United States, 1 510(k) clearance
Rhinosystems, Inc. is registered with the FDA (registration 3007644779) in Brooklyn, OH, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 27, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007644779
- Address
- 1 American Road Suite 1100, Brooklyn, OH, United States, 44144
- Owner or operator
- RhinoSystems, Inc. (10029295)
- Roles
- Specification developer
- First device listed
- April 28, 2009
- Registered through
- 2027
- Brand names listed
- Navage Advanced Nose Cleaner, Navage Baby Micro Mist Inhaler, Navage Dual Action Powered Ear Cleaner, Navage Nasal Aspirator, Navage Nebulizer, Navage Portable Nebulizer, Navage Portable Nose Cleaner, Navage Portable Powered Nose Cleaner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent | KCJ | 1 | Specification developer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Specification developer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Specification developer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | 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 |
|---|---|---|---|---|---|---|
| June 27, 2014 | K140542 | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | KMA | Substantially Equivalent | Rhinosystems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Applicator, Ent
- All makers of Nasal Spray, Ent Delivery
- All makers of Irrigator, Powered Nasal
- All makers of Bottle, Collection, Vacuum
Updated June 27, 2014. 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.