EVOLVE Nitric Oxide Delivery System— 510(k) K242578

Name: FDA 510(k) clearance K242578
Creator: U.S. Food and Drug Administration
Published: 2025-01-03

Substantially Equivalent

Mallinckrodt Manufacturing, LLC

FDA 510(k) clearance K242578 for EVOLVE Nitric Oxide Delivery System, Substantially Equivalent on 2025-01-03. Applicant: Mallinckrodt Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Mallinckrodt Manufacturing, LLC
Product code: Code MRN
Device class: Class 2
Regulation: 21 CFR 868.5165
Advisory panel: Anesthesiology
Date received: 2024-08-29
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRN

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K242374 — ULSPIRA TS Nitric Oxide Therapy System2025-01-17
K240410 — EVOLVE Nitric Oxide Delivery System2024-05-28
K233251 — NOxBOXi Nitric Oxide Delivery System2024-05-23
K222930 — Evolve Nitric Oxide Delivery System2023-12-06
K231823 — NOxBOXi Nitric Oxide Delivery System2023-08-11

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K211153 — Inomax DSIR2023-04-20
K200389 — INOmax DSIR Plus2020-06-17

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.