# K150591: Besmed Reusable Jet Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Jun 30, 2015 after 113 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. The Besmed Reusable Jet Nebulizer is intended for use with pediatric (2 years and older) and as defined by the prescribed medication and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

Source page: https://510kreport.com/device/K150591
Methodology: https://510kreport.com/methodology