Skip to content

INOmax DSIR Plus MRI

by Ino Therapeutics/Ikaria

510(k) K143213

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143213 Date10 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MRN
Device Class
Class II
Regulation
21 CFR Part 868.5165
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The INOmax DSIR Plus MRI is an Apparatus for Nitric Oxide Delivery, classified under product code MRN and device class II. It is designed to deliver nitric oxide gas for inhalation.

This device received FDA 510(k) clearance (K143213) on July 10, 2015, following a traditional review process. It is manufactured by Ino Therapeutics/Ikaria in Madison, Wisconsin, and is intended for use in accordance with the indications, usage, contraindications, and warnings described in the INOmax package inserts and labeling.

Other devices from Ino Therapeutics/Ikaria

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the INOmax DSIR Plus MRI used for?

    The INOmax DSIR Plus MRI is an apparatus designed to deliver nitric oxide gas for inhalation, as specified in its labeling and intended for use in accordance with the indications, usage, contraindications, and warnings described in the INOmax package inserts.

  • How is the INOmax DSIR Plus MRI supplied and is it reusable?

    The device is supplied as a complete apparatus for nitric oxide delivery and is intended for repeated use under the conditions specified in the labeling; it is not described as single-use in the provided data.

  • What regulatory pathway was used for the INOmax DSIR Plus MRI?

    The INOmax DSIR Plus MRI received FDA 510(k) clearance (K143213) on July 10, 2015, following a traditional review process and was found substantially equivalent to a predicate device.