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510(k) K240410

EVOLVE Nitric Oxide Delivery System by Malinckrodt Manufacturing, LLC — Product Code MRN

K240410 is an FDA 510(k) premarket notification submitted by Malinckrodt Manufacturing, LLC for the device "EVOLVE Nitric Oxide Delivery System". The FDA issued a decision of Substantially Equivalent on May 28, 2024. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2024
Date Received
February 12, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Nitric Oxide Delivery
Device Class
Class II
Regulation Number
868.5165
Review Panel
AN
Submission Type

Other clearances for product code MRN

  • K242374 — ULSPIRA TS™ Nitric Oxide Therapy System (January 17, 2025)
  • K242578 — EVOLVE Nitric Oxide Delivery System (January 3, 2025)
  • K233251 — NOxBOXi Nitric Oxide Delivery System (May 23, 2024)
  • K222930 — Evolve Nitric Oxide Delivery System (December 6, 2023)
  • K231823 — NOxBOXi Nitric Oxide Delivery System (August 11, 2023)
  • K212409 — Ulspira TS Nitric Oxide Therapy System (June 30, 2023)
  • K211153 — Inomax DSIR (April 20, 2023)
  • K220898 — NOxBOXi Nitric Oxide Delivery System (April 27, 2022)
  • K201339 — The NOxBOXi Nitric Oxide Delivery System (June 19, 2020)
  • K200389 — INOmax DSIR Plus (June 17, 2020)

FDA data resources