ULSPIRA TS Nitric Oxide Therapy System— 510(k) K242374

Name: FDA 510(k) clearance K242374
Creator: U.S. Food and Drug Administration
Published: 2025-01-17

Substantially Equivalent

Airgas Therapeutics, LLC

FDA 510(k) clearance K242374 for ULSPIRA TS Nitric Oxide Therapy System, Substantially Equivalent on 2025-01-17. Applicant: Airgas Therapeutics, LLC. Device class: 2.

Clearance details

Applicant: Airgas Therapeutics, LLC
Product code: Code MRN
Device class: Class 2
Regulation: 21 CFR 868.5165
Advisory panel: Anesthesiology
Date received: 2024-08-09
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Plumsteadville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRN

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K242578 — EVOLVE Nitric Oxide Delivery System2025-01-03
K240410 — EVOLVE Nitric Oxide Delivery System2024-05-28
K233251 — NOxBOXi Nitric Oxide Delivery System2024-05-23
K222930 — Evolve Nitric Oxide Delivery System2023-12-06
K231823 — NOxBOXi Nitric Oxide Delivery System2023-08-11

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.