# K222930: Evolve Nitric Oxide Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Manufacturing, LLC
- Decided: Dec 6, 2023 after 436 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K240410: EVOLVE Nitric Oxide Delivery System (2024), 1 descendant of its own
- K242578: EVOLVE Nitric Oxide Delivery System (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K222930
Methodology: https://510kreport.com/methodology