Class Class II
ULSPIRA TS™ Nitric Oxide Therapy System (K242374)
Description
ULSPIRA TS™ Nitric Oxide Therapy System by Airgas Therapeutics, LLC, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242374
Clearance Date2025-01-17
Clearance TypeSpecial
Product CodeMRN
Regulation Number868.5165
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242374
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ULSPIRA TS™ Nitric Oxide Therapy System (K242374) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023 |
Trace the full predicate network for K242374
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.