# K211153: Inomax DSIR

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Manufacturing, LLC
- Decided: Apr 20, 2023 after 731 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003665 (2001). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200389: INOmax DSIR Plus, Mallinckrodt Manufacturing, LLC (2020) Summary page 4.
- K131686: Inomax Dsir (Delivery System), Ino Therapeutics/Ikaria (2013) Summary page 6.

## Indications for use
The INOmax® DSIR Plus delivery system delivers INOMAX® (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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with. The INOmax® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup. The INOmax® DSIR Plus must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. 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/K211153
Methodology: https://510kreport.com/methodology