# K080797: Humidaire 2I

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 9, 2008 after 111 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 K974417 (1998). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013843: Autoset Spirit Cpap System, Resmed Corp (2002) Summary page 1.
- K051364: Vpap Adapt, Resmed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K131388: Transcend Heated Humidifier (2013), 1 descendant of its own
- K180388: Transcend 365 miniCPAP System (2018), 0 descendants of its own

## Indications for use
The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device. The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment. The HumidAire 2i is for use only as recommended by a physician.

Source page: https://510kreport.com/device/K080797
Methodology: https://510kreport.com/methodology