# K093260: Aeronox Nitric Oxide Titration & Monitoring System

- Pathway: 510(k) (Special)
- Applicant: International Biomedical, Ltd.
- Decided: Dec 16, 2009 after 58 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: 1 generation back to K000653 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K193481: AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (2020), 0 descendants of its own

## Indications for use
The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.

Source page: https://510kreport.com/device/K093260
Methodology: https://510kreport.com/methodology