# K200389: INOmax DSIR Plus

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Manufacturing, LLC
- Decided: Jun 17, 2020 after 120 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: 12 generations back to K003665 (2001). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131686: Inomax Dsir (Delivery System), Ino Therapeutics/Ikaria (2013) Summary page 4.

## Most influential descendants
- 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

## 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 most ventilators. 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 target patient population is controlled by the drug labeling for INOMAX® 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/K200389
Methodology: https://510kreport.com/methodology