Data / Medical devices / United States / Spirair
Spirair: FDA-registered device maker in Mountain View, CA, United States, 3 510(k) clearances
Spirair is registered with the FDA (registration 3043562110) in Mountain View, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3043562110
- Address
- 2570 W El Camino Real Ste 310, Mountain View, CA, United States, 94040
- Owner or operator
- Spirair, Inc (10090843)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- August 26, 2025
- Registered through
- 2026
- Brand names listed
- SeptAlign, TurbAlign
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | 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 |
|---|---|---|---|---|---|---|
| July 30, 2026 | K260620 | SeptAlign (SPLN001) | NHB | Substantially Equivalent | Spirair, Inc. | accessdata.fda.gov |
| January 16, 2026 | K251790 | SeptAlign | NHB | Substantially Equivalent | Spirair, Inc. | accessdata.fda.gov |
| July 11, 2025 | K243655 | TurbAlign | LYA | Substantially Equivalent | Spirair, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- All makers of Splint, Intranasal Septal
Updated July 30, 2026. 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.