# K990506: Mabis NB-02 Ultrasonic Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Mabis Healthcare, Inc.
- Decided: Mar 11, 1999 after 22 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices 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.

## Most influential descendants
- K061381: LC Star with Nasal Adapter (2006), 5 descendants of its own
- K092918: Pari Vios (2010), 2 descendants of its own
- K191270: Proneb Max (2020), 0 descendants of its own
- K131881: Ombra Table Top Compressor (2013), 0 descendants of its own
- K092560: Pari Sinus (2010), 0 descendants of its own

## Indications for use
The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Source page: https://510kreport.com/device/K990506
Methodology: https://510kreport.com/methodology