# K050314: Aquinox

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Feb 18, 2005 after 9 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- 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 K894000 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894000: Thera-Mist Humidifier, Pegasus Research Corp. (1989) Summary page 1.
- K000401: Vapotherm, Model 2000I, Vapotherm, Inc. (2000) Summary page 1.

## Most influential descendants
- K070107: Pari Hydrate G (2007), 0 descendants of its own

## Indications for use
AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.

Source page: https://510kreport.com/device/K050314
Methodology: https://510kreport.com/methodology