Data / Medical devices / United States / Freespira, Inc
Freespira, Inc: FDA-registered device maker in Kirkland, WA, United States, 3 510(k) clearances
Freespira, Inc is registered with the FDA (registration 3010887638) in Kirkland, WA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010887638
- Address
- 12020 113th Ave NE Ste 215, Kirkland, WA, United States, 98034
- Owner or operator
- Palo Alto Health Sciences (10046775)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Specification developer
- First device listed
- May 10, 2014
- Registered through
- 2026
- Brand names listed
- Canary Breathing System, Freespira, Freespira Breathing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety | SEN | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Complaint file establishment, Manufacturer, Remanufacturer, 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 |
|---|---|---|---|---|---|---|
| April 24, 2025 | K233337 | Freespira Breathing System | SEN | Substantially Equivalent | Freespira, Inc. | accessdata.fda.gov |
| August 23, 2018 | K180173 | Freespira | HCC | Substantially Equivalent | Palo Alto Health Sciences, Inc. | accessdata.fda.gov |
| December 10, 2013 | K131586 | CANARY BREATHING SYSTEM | HCC | Substantially Equivalent | Palo Alto Health Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 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.