# K131686: Inomax Dsir (Delivery System)

- Pathway: 510(k) (Traditional)
- Applicant: Ino Therapeutics/Ikaria
- Decided: Nov 29, 2013 after 172 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003665 (2001). 19 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003, Ino Therapeutics (2006) Summary page 1.
- K070867: Inomax DS (Delivery System), Model 10003, Ino Therapeutics, LLC (2007) Summary page 1.
- K071516: Inomax DS, Ino Therapeutics, LLC (2007) Summary page 1.
- K080484: Inomax DS (Delivery System), Model 10003, Ino Therapeutics (2008) Summary page 1.
- K081691: Inomax DS (Delivery System), Ino Therapeutics, LLC (2008) Summary page 1.
- K090958: Inomax DS (Delivery System), Ino Therapeutics, LLC (2009) Summary page 1.
- K092545: Inomax DS (Delivery System), Model 10003, Ino Therapeutics, LLC (2010) Summary page 1.
- K093922: Inomax DS, Ino Therapeutics (2010) Summary page 1.
- K110344: Inomax Dsir (Delivery System), Ino Therapeutics (2011)
- K110635: Inomax DS (IR) (Delivery System), Ino Therapeutics, LLC/Dba Ikaria (2011)
- K113272: Inomax DS (Delivery Systems, Ino Therapeutics, LLC/Dba Ikaria (2012) Summary page 1.
- K121021: Inomax DS (Delivery System), Ino Therapeutics (2012) Summary page 1.
- K130605: Inomax Dsir (Delivery System), Ino Therapeutics (2013) Summary page 1.

## Most influential descendants
- K200389: INOmax DSIR Plus (2020), 3 descendants of its own
- K212409: Ulspira TS Nitric Oxide Therapy System (2023), 1 descendant of its own
- K242374: ULSPIRA TS™ Nitric Oxide Therapy System (2025), 0 descendants of its own
- K211153: Inomax DSIR (2023), 0 descendants of its own
- K143213: INOmax DSIR Plus MRI (2015), 0 descendants of its own

## Recalls of this device
- Jul 9, 2018 · Class II · Z-2733-2018: INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct exp
- Nov 21, 2016 · Class II · Z-1076-2017: Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
- Oct 17, 2014 · Class II · Z-0575-2015: An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactu
- Mar 27, 2014 · Class II · Z-1528-2014: An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended

## Indications for use
The INOmax* DS delivery system delivers INOMvAXO (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOmaxDS Orovides continuous integrated monitoring of inspired 02, N02, and NO, and a comprehensive alarm system. The iNOmaxv DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmaxo DS includes a backup NO delivery capability that provides a fixe'dflow of 250 niL/min of NO which along with user supplied 10 Llnin of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the lNOblendero for backup. The target patient population is controlled by the drug labeling for INOMAXO and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

Source page: https://510kreport.com/device/K131686
Methodology: https://510kreport.com/methodology