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INOMAX DSIR Delivery System

by Ino Therapeutics 2 variants

510(k) K130605

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 · Special NumberK130605 Date2 May 2013ClearedStatusActive

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  • Withdrawn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, 25 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 Delivery System is an apparatus for delivering nitric oxide gas for inhalation. It is designed to deliver INOmax therapy gas into the inspiratory limb of the patient breathing circuit. This system is classified under product code MRN as Apparatus, Nitric Oxide Delivery.

The INOMAX DSIR Delivery System is a Class II device with special controls, cleared by the FDA on May 2, 2013 under 510(k) number K130605. It is manufactured by Ino Therapeutics in Madison, US. The device must be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOmax package inserts and labeling.

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Questions

AI-generated answers, 25 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 Delivery System used for?

    The INOMAX DSIR Delivery System is an apparatus designed to deliver INOmax therapy gas into the inspiratory limb of a patient's breathing circuit for inhalation treatment. It must be used according to the indications and precautions in the INOmax package inserts and labeling.

  • How is the INOMAX DSIR Delivery System supplied and what are its sterility requirements?

    The device is supplied as a complete delivery system apparatus. While the device data doesn't specify sterility requirements, it is designed to deliver nitric oxide gas directly into the patient breathing circuit, suggesting it must maintain appropriate hygiene standards for medical use.

  • Is the INOMAX DSIR Delivery System reusable or single-use?

    The device data doesn't explicitly state whether the INOMAX DSIR Delivery System is reusable or single-use. However, as a delivery system for medical gases, it may be designed for either configuration depending on the specific model and intended use.

  • What regulatory status does the INOMAX DSIR Delivery System have?

    The INOMAX DSIR Delivery System is a Class II device with special controls, cleared by the FDA on May 2, 2013 under 510(k) number K130605. It is manufactured by Ino Therapeutics in Madison, US, and must be used according to the indications, usage, contraindications, warnings and precautions described in the INOmax package inserts and labeling.