# K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003

- Pathway: 510(k) (Traditional)
- Applicant: Ino Therapeutics
- Decided: Dec 14, 2006 after 162 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003665 (2001). 6 ancestors in all.
24 later devices descend from it; 14 cite it directly.
5 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000186: Datex-Ohmeda Inovent Delivery System, Datex-Ohmeda (2000) Summary page 1.
- K052663: Ino Therapeutics Inoblender, Model 10004, Ino Therapeutics (2005) Summary page 1.
- K023014: Vianox Delivery System, Model I, Pulmonox Medical, Inc. (2003) Summary page 1.
- K000653: Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox Transport Transport, Model P/N 360002, Pulmonox Medical Corp. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K974562: Ohmeda INOvent Delivery System (now GE Healthcare). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K092545: Inomax DS (Delivery System), Model 10003 (2010), 16 descendants of its own
- K070867: Inomax DS (Delivery System), Model 10003 (2007), 15 descendants of its own
- K071516: Inomax DS (2007), 14 descendants of its own
- K093922: Inomax DS (2010), 11 descendants of its own
- K090958: Inomax DS (Delivery System) (2009), 11 descendants of its own

## Recalls of this device
- Jun 23, 2022 · Class II · Z-1745-2022: The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni P
- Nov 30, 2010 · Not classified · Z-0583-2012: Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non repo
- Jul 21, 2010 · Not classified · Z-2176-2010: The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOM

## Indications for use
The INOmax DS delivery system delivers INOmax® (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 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 1NOblender 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/K061901
Methodology: https://510kreport.com/methodology