# K000653: Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox Transport Transport, Model P/N 360002

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonox Medical Corp.
- Decided: Aug 4, 2000 after 158 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
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K000653
Methodology: https://510kreport.com/methodology