Airgas Therapeutics, LLC: FDA clearances and approvals
Airgas Therapeutics, LLC has 2 FDA 510(k) clearances (first 2023, latest 2025), plus 2 PMA decisions, across 2 product codes in 2 review panels. Median 510(k) review time: 428 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 696 |
| 2024 | 0 | — |
| 2025 | 1 | 161 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Airgas Therapeutics, LLC's cleared 510(k)s took a median 428 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | 2 | 0 |
| MRN | Apparatus, Nitric Oxide Delivery | 2 | 2 |
Review panels
- Anesthesiology (2)
- Ophthalmic (2)
Most recent Airgas Therapeutics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242374 | ULSPIRA TS Nitric Oxide Therapy System | MRN | 2025-01-17 | 161 |
| K212409 | Ulspira TS Nitric Oxide Therapy System | MRN | 2023-06-30 | 696 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P900066 | PMA | PERFLUOROPROPANE | 1993-02-25 |
| P900067 | PMA | SULFUR HEXAFLUORIDE | 1993-02-25 |
Recalls
openFDA lists no recalls under a recalling firm named Airgas Therapeutics, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Airgas Therapeutics, LLC have?
Airgas Therapeutics, LLC has 2 FDA 510(k) clearances (first 2023, latest 2025), plus 2 PMA decisions, across 2 product codes in 2 review panels.
How long does FDA take to clear Airgas Therapeutics, LLC's 510(k)s?
The median time from FDA receipt to decision across Airgas Therapeutics, LLC's cleared 510(k)s is 428 days.
What devices does Airgas Therapeutics, LLC make?
Its most frequent FDA product codes are LPO (Gases Used Within Eye To Place Pressure On Detached Retina, 2); MRN (Apparatus, Nitric Oxide Delivery, 2).
Has Airgas Therapeutics, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Airgas Therapeutics, LLC. Related entities may recall under other names.
Next steps
- See all 2 Airgas Therapeutics, LLC clearances with predicates and recalls
- Run predicate analysis for product code LPO, Airgas Therapeutics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.