# K023014: Vianox Delivery System, Model I

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonox Medical, Inc.
- Decided: Aug 14, 2003 after 338 days
- Product code: MRP (Analyzer, Nitric Oxide)
- Device class: 2
- Regulation: 21 CFR 868.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 1 cites it directly.
5 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) INOvent Delivery System: named in the summary without a submission number

## Most influential descendants
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003 (2006), 24 descendants of its own
- 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

## Indications for use
The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.

Source page: https://510kreport.com/device/K023014
Methodology: https://510kreport.com/methodology