# K193411: O2asis Personal Oxygen Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Perma Pure, LLC
- Decided: Nov 12, 2020 after 339 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: 3 generations back to K000401 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042245: Vapotherm Model#2000I, 200H, Vapotherm, Inc. (2004) Summary page 4.

## Indications for use
The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.

Source page: https://510kreport.com/device/K193411
Methodology: https://510kreport.com/methodology