# K212395: Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Homed Medical Device Co., Ltd.
- Decided: Mar 25, 2022 after 235 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: 3 generations back to K883964 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091272: Besmed Jet Nebulizer Bottle Set, Besmed Health Business Corp (2009) Summary page 4.

## Indications for use
The JLI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. The JLI nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.

Source page: https://510kreport.com/device/K212395
Methodology: https://510kreport.com/methodology