# K102240: Nivo Nebulizer System

- Pathway: 510(k) (Special)
- Applicant: Aerogen Ireland, Ltd.
- Decided: Nov 10, 2010 after 93 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 NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask. The Aeroneb®R Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual. The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.

Source page: https://510kreport.com/device/K102240
Methodology: https://510kreport.com/methodology