Submission Details
| 510(k) Number | K242374 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 09, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 161 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
ULSPIRA TS? Nitric Oxide Therapy System
Jan 2025
Decision
161d
Days
Class 2
Risk
About This 510(k) Submission
K242374 is an FDA 510(k) clearance for the ULSPIRA TS? Nitric Oxide Therapy System, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by Airgas Therapeutics, LLC (Plumsteadville, US). The FDA issued a Cleared decision on January 17, 2025, 161 days after receiving the submission on August 9, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.
Device Classification
| Product Code | MRN — Apparatus, Nitric Oxide Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5165 |
Manufacturer
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