# K092545: Inomax DS (Delivery System), Model 10003

- Pathway: 510(k) (Special)
- Applicant: Ino Therapeutics, LLC
- Decided: Mar 10, 2010 after 203 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: 4 generations back to K003665 (2001). 7 ancestors in all.
16 later devices descend from it; 7 cite it directly.
5 of 24 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.

## Most influential descendants
- K110344: Inomax Dsir (Delivery System) (2011), 9 descendants of its own
- K110635: Inomax DS (IR) (Delivery System) (2011), 9 descendants of its own
- K113272: Inomax DS (Delivery Systems (2012), 8 descendants of its own
- K121021: Inomax DS (Delivery System) (2012), 7 descendants of its own
- K130605: Inomax Dsir (Delivery System) (2013), 6 descendants of its own

## Indications for use
The INOmax DS delivery system delivers mNOmaxO~ (nitric oxide of 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 DS provides continuous integrated monitoring of inspired 02, NO 2, and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 nmL/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 rNOblender for backup. The target patient population is controlled by the drug labeling for TNOmax 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/K092545
Methodology: https://510kreport.com/methodology