Data / Medical devices / United States / Airway Management Inc.
Airway Management Inc.: FDA-registered device maker in Farmers Branch, TX, United States, 5 510(k) clearances
Airway Management Inc. is registered with the FDA (registration 3003496134) in Farmers Branch, TX, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 11, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003496134
- Address
- 4300 Alpha Road SUITE 115, Farmers Branch, TX, United States, 75244
- Owner or operator
- AIRWAY MANAGEMENT INC. (9059181)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- October 17, 2003
- Registered through
- 2026
- Brand names listed
- AM Aligner, BITE REGISTRATION; TAP GAUGE, MyTAP, Nylon flexTAP, TAP 3 Elite, TAP I, TAP III, TAP T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 11, 2025 | K252374 | Nylon flexTAP(R) | LRK | Substantially Equivalent | Airway Technologies D/B/A Airway Management | accessdata.fda.gov |
| November 1, 2012 | K122350 | TAP PAP NASAL PILLOW MASK | BZD | Substantially Equivalent | Airway Management, Inc. | accessdata.fda.gov |
| December 12, 2006 | K062951 | TAP III ANTI-SNORING DEVICE | LRK | Substantially Equivalent | Airway Management, Inc. | accessdata.fda.gov |
| July 12, 2006 | K061732 | TAP-T | LRK | Substantially Equivalent | Airway Management, Inc. | accessdata.fda.gov |
| August 21, 1997 | K972061 | TOA | LRK | Substantially Equivalent | W. Keith Thornton, D.D.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Mouthpiece, Breathing
- All makers of Device, Anti-Snoring
- All makers of Material, Impression Tray, Resin
- All makers of Positioner, Tooth, Preformed
- All makers of Gauge, Depth, Instrument, Dental
Updated September 11, 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.