# K113542: Salter Labs Bubble Humidifier (High Flow)

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs, Arvin Facility
- Decided: Feb 10, 2012 after 71 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: 2 generations back to K991484 (1999). 2 ancestors in all.
2 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.
- K041963: American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi, American Bantex Corp. (2004) Summary page 1.

## Most influential descendants
- 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 bubble humidifier is a device that is intended to add moisture to breathing gases for administration to a patient. The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

Source page: https://510kreport.com/device/K113542
Methodology: https://510kreport.com/methodology