Data / Medical devices / United States / Pneuma Therapeutics, Inc.
Pneuma Therapeutics, Inc.: FDA-registered device maker in San Marcos, CA, United States, 1 510(k) clearance
Pneuma Therapeutics, Inc. is registered with the FDA (registration 3045323840) in San Marcos, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045323840
- Address
- 1253 Holmgrove Dr, San Marcos, CA, United States, 92078
- Owner or operator
- Pneuma Therapeutics, Inc. (10095797)
- Roles
- Specification developer
- First device listed
- April 30, 2026
- Registered through
- 2026
- Brand names listed
- XChange Oxygen Therapy Positive Pressure Interface with Integrated End Tidal CO2 Sampling
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Specification developer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | 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 |
|---|---|---|---|---|---|---|
| January 30, 2023 | K210112 | XChange Device, XChange System | CCK | Substantially Equivalent | Pneuma Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 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.