# K970542: Master Neb II

- Pathway: 510(k) (Traditional)
- Applicant: Bremed Italia, S.R.L.
- Decided: Jun 24, 1997 after 132 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 an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist. 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 hand held nebulizers that are currently in distribution in the United States and Europe. The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.

Source page: https://510kreport.com/device/K970542
Methodology: https://510kreport.com/methodology