Data / Medical devices / United States / Telesair, Inc.
Telesair, Inc.: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Telesair, Inc. is registered with the FDA (registration 3021947238) in Irvine, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021947238
- Address
- 199 Technology Drive Suite 110, Irvine, CA, United States, 92618
- Owner or operator
- Telesair, Inc. (10084443)
- Roles
- Manufacturer
- First device listed
- November 9, 2023
- Registered through
- 2026
- Brand names listed
- AVEA disposable expiratory filter/water trap, Bonhawa Respiratory Humidifier, Heated Breathing Set, Nasal Cannula, Trolley
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Portable Liquid Oxygen Unit Stand | PCM | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 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 |
|---|---|---|---|---|---|---|
| May 8, 2025 | K251133 | AVEA disposable expiratory filter/water trap (11790) | CBK | Substantially Equivalent | Telesair, Inc. | accessdata.fda.gov |
| October 13, 2023 | K223863 | BONHAWA Respiratory Humidifier | BTT | Substantially Equivalent | Telesair, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Ventilator, Continuous, Facility Use
- All makers of Cannula, Nasal, Oxygen
- All makers of Portable Liquid Oxygen Unit Stand
Updated May 8, 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.