# K041418: Airlife Misty Finity Large Volume Continuous Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Jun 10, 2004 after 14 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Westmed Heart Continuous Large Volume Nebulizer: named in the summary without a submission number

## Most influential descendants
- K220955: Hudson RCI Variable concentration Large Volume Nebulizer (1770) (2023), 0 descendants of its own

## Indications for use
This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Continuous Large Volume Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used under medical supervision in hospitals, nursing homes, extended care facilities or outpatient clinics.

Source page: https://510kreport.com/device/K041418
Methodology: https://510kreport.com/methodology