Data / Medical devices / United States / Bryan Medical Inc.
Bryan Medical Inc.: FDA-registered device maker in Cincinnati, OH, United States, 2 510(k) clearances
Bryan Medical Inc. is registered with the FDA (registration 3005803389) in Cincinnati, OH, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 25, 2020. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005803389
- Address
- 6100 Wooster Pike, Cincinnati, OH, United States, 45227
- Owner or operator
- Bryan Medical Inc. (10029737)
- Roles
- Specification developer
- First device listed
- July 10, 2015
- Registered through
- 2026
- Brand names listed
- Tenax, Tenax Laser Resistant Endotracheal Tube Convenience Kit, aeris
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope Accessory | KTI | 2 | Specification developer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Specification developer | accessdata.fda.gov |
| Orotracheal Intubation Guide Kit | OGK | 2 | Specification developer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | 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 |
|---|---|---|---|---|---|---|
| November 25, 2020 | K200761 | Tenax Laser Resistant Endotracheal Tube | BTR | Substantially Equivalent | Bryan Medical, Inc. | accessdata.fda.gov |
| June 25, 2015 | K150951 | aeris Balloon Dialation Catheter | KTI | Substantially Equivalent | Bryan Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 16, 2023 | 92558 | Class II | Ongoing | Aeris Balloon Dilation Catheter | Devices were mislabeled. | accessdata.fda.gov |
| April 17, 2013 | 65449 | Class I | Terminated | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | accessdata.fda.gov |
Compare with other makers
- All makers of Orotracheal Intubation Guide Kit
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Bronchoscope Accessory
Updated July 17, 2023. 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.