# K991484: Airlife Bubble Humidifer, Model 002003 and 002006

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: May 13, 1999 after 15 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Airlife® Bubble Humidifiers: named in the summary without a submission number

## Most influential descendants
- K041963: American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi (2004), 3 descendants of its own
- K113542: Salter Labs Bubble Humidifier (High Flow) (2012), 2 descendants of its own
- K161719: Salter Labs Bubble Humidifier (2017), 1 descendant of its own
- K230559: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) (2023), 0 descendants of its own
- K062091: Porous Media Humidiflow Humidifier for Universal Humidification (2006), 0 descendants of its own

## Indications for use
Humidifiers are defined as a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient.

Source page: https://510kreport.com/device/K991484
Methodology: https://510kreport.com/methodology