# K161719: Salter Labs Bubble Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Sep 21, 2017 after 456 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 K991484 (1999). 3 ancestors in all.
1 later device descends 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)
- K113542: Salter Labs Bubble Humidifier (High Flow), Salter Labs, Arvin Facility (2012) Summary page 4.

## Most influential descendants
- 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 intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice. 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/K161719
Methodology: https://510kreport.com/methodology