# K242374: ULSPIRA TS™ Nitric Oxide Therapy System

- Pathway: 510(k) (Special)
- Applicant: Airgas Therapeutics, LLC
- Decided: Jan 17, 2025 after 161 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K003665 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212409: Ulspira TS Nitric Oxide Therapy System, Airgas Therapeutics (2023) Summary page 5.

## Indications for use
The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, N02 and 02 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy. The Ulspira TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use. The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes: * Continuous integrated monitoring for inspired NO, N02 and 02 and a comprehensive alarm system. * A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb. * Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low 02 pressure alarm when using an oxygen cylinder. * An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy. * Compatibility with a wide inspiratory flow rate range of 0.25-120 I/min, utilizing an automatically detected low or high flow sensor. * An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access. The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with 02, for iNO therapy which allows continuous treatment during transit within hospitals.

Source page: https://510kreport.com/device/K242374
Methodology: https://510kreport.com/methodology