Data / Medical devices / United States / Airgas Therapeutics LLC
Airgas Therapeutics LLC: FDA-registered device maker in Plumsteadville, PA, United States, 2 510(k) clearances and 2 PMA approvals
Airgas Therapeutics LLC is registered with the FDA (registration 2518435) in Plumsteadville, PA, United States. It lists 15 device types. The FDA files 2 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2518435
- Address
- 6141 Easton Road P/O. Box 310, Plumsteadville, PA, United States, 18949
- Owner or operator
- Airgas Therapeutics LLC (10084091)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 17, 2022
- Registered through
- 2026
- Brand names listed
- Aerobic Anaerobic Gas Mixture, Aerobic/Anaerobic Gas Mixture, Blood gas Mixture, Calibration Mixture, Gas Cylinder Pressure Regulator, Laser Gas Mixture, Lung Diffusion Mixture, OCS Liver and more
Devices it lists
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 17, 2025 | K242374 | ULSPIRA TS Nitric Oxide Therapy System | MRN | Substantially Equivalent | Airgas Therapeutics, LLC | accessdata.fda.gov |
| June 30, 2023 | K212409 | Ulspira TS Nitric Oxide Therapy System | MRN | Substantially Equivalent | Airgas Therapeutics | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 25, 1993 | P900067 | SULFUR HEXAFLUORIDE | LPO | 5 | January 20, 2012 | accessdata.fda.gov |
| February 25, 1993 | P900066 | PERFLUOROPROPANE | LPO | 13 | April 30, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Apparatus, Nitric Oxide Delivery
Updated January 17, 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.