# K041963: American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi

- Pathway: 510(k) (Traditional)
- Applicant: American Bantex Corp.
- Decided: Oct 20, 2004 after 91 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 K991484 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991484: Airlife Bubble Humidifer, Model 002003 and 002006, Allegiance Healthcare Corp. (1999) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The American Bantex Humidifier is intended for use with oxygen concentrators or gas sources in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration directly to the patient.

Source page: https://510kreport.com/device/K041963
Methodology: https://510kreport.com/methodology