# K230559: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 26, 2023 after 240 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: 4 generations back to K991484 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161719: Salter Labs Bubble Humidifier, Salter Labs (2017) Summary page 5.

## Indications for use
Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

Source page: https://510kreport.com/device/K230559
Methodology: https://510kreport.com/methodology