510(k) clearance

ULSPIRA TS™ Nitric Oxide Therapy System

FDA 510(k) source

510(k) number

K253095

Applicant

Airgas Therapeutics, LLC

Decision date

Oct 30, 2026

Date received

Sep 23, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MRN

Device type

Apparatus, Nitric Oxide Delivery

Device class

Class II

Regulation

21 CFR 868.5165

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Plumsteadville, PA, US