# K220955: Hudson RCI Variable concentration Large Volume Nebulizer (1770)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industires, Inc.
- Decided: Jun 23, 2023 after 448 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 K041418 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041418: Airlife Misty Finity Large Volume Continuous Nebulizer, Cardinalhealth (2004) Summary page 4.

## Indications for use
The non-prefilled nebulizer is indicated for use when humidity needs to be added to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.

Source page: https://510kreport.com/device/K220955
Methodology: https://510kreport.com/methodology