Home / 510(k) Clearances / K113272

510(k) K113272

INOMAX DS(DELIVERY SYSTEMS by Ino Therapeutics, LLC/Dba Ikaria — Product Code MRN

K113272 is an FDA 510(k) premarket notification submitted by Ino Therapeutics, LLC/Dba Ikaria for the device "INOMAX DS(DELIVERY SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 29, 2012. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics, LLC/Dba Ikaria has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2012
Date Received
November 4, 2011
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 by Ino Therapeutics, LLC/Dba Ikaria

  • K110635 — INOMAX DS(IR) (DELIVERY SYSTEM) (June 23, 2011)

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)
  • K240410 — EVOLVE Nitric Oxide Delivery System (May 28, 2024)
  • 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)

FDA data resources