Ino Therapeutics Inomax Ds (Delivery System), Model 10003

• • Ongoing Z-1745-2022 FDA Class II ·initiated 23 Jun 2022

  The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.

• • Terminated Z-0583-2012 FDA Unclassified (pre-2012) ·initiated 30 Nov 2010

  Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.

• • Terminated Z-2176-2010 FDA Unclassified (pre-2012) ·initiated 21 Jul 2010

  The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm

510(k) Number

K061901 ↗

FDA Product Code

MRN

Device Class

Class II

Regulation

21 CFR Part 868.5165

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Inomax Ds (Delivery System)

  Class II

  FDA 510(k) K121021 Active Cleared 24 Sep 2012

• Inomax Ds (Delivery System), Model 10003

  Class II

  FDA 510(k) K092545 Active Cleared 10 Mar 2010

• Inomax Dsir (Delivery System)

  Class II

  FDA 510(k) K110344 Active Cleared 24 Jun 2011

• Inomax Ds

  Class II

  FDA 510(k) K071516 Active Cleared 3 Oct 2007

• INOMAX DSIR Delivery System

  Class II

  FDA 510(k) K130605 Active Cleared 2 May 2013

• Inoblender

  Class II

  FDA 510(k) K122689 Active Cleared 7 Nov 2012

See all devices from Ino Therapeutics →