FDA Cleared
New Device
Pathway: 510K
ULSPIRA TS Nitric Oxide Therapy System
Applicant:
Airgas Therapeutics, LLC
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
MRN
Review Panel:
Anesthesiology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2025-09-23
Decision Date:
2026-10-30
Total Review Duration:
402 calendar days (402 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Timothy Warren
Role: SUBMITTER_CONTACT
Notice a discrepancy or outdated information on this record?
Report to support@fdacleared.org