Class Class II
EVOLVE Nitric Oxide Delivery System (K242578)
Description
EVOLVE Nitric Oxide Delivery System by Mallinckrodt Manufacturing, LLC, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242578
Clearance Date2025-01-03
Clearance TypeSpecial
Product CodeMRN
Regulation Number868.5165
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242578
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. EVOLVE Nitric Oxide Delivery System (K242578) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | 2024 |
Trace the full predicate network for K242578
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.