# K982043: Breneb

- Pathway: 510(k) (Traditional)
- Applicant: Bremed Italia, S.R.L.
- Decided: Nov 9, 1998 after 152 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
This product is a hand held nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma or emphysema. The device creates acrosolized particles of the prescribed medication via interface with a nebulizer compressor. The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles. The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer. The treatment lasts as per his/her physicians orders. This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices. The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe. The components found within this product are safe and common items.

Source page: https://510kreport.com/device/K982043
Methodology: https://510kreport.com/methodology