# K143213: INOmax DSIR Plus MRI

- Pathway: 510(k) (Traditional)
- Applicant: Ino Therapeutics/Ikaria
- Decided: Jul 10, 2015 after 242 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.
No later device cites it as a predicate yet.
0 of 21 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.

## Indications for use
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of 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. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling. The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired O2, NO2, and NO. The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.

Source page: https://510kreport.com/device/K143213
Methodology: https://510kreport.com/methodology