# K990435: Bestneb Portable Aerosol Therapy Unit, AP-100100

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Jun 5, 2000 after 480 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K121969: U-Right Compressor Nebulizer (2013), 1 descendant of its own
- K192633: GUS831 Compressor Nebulizer (2020), 0 descendants of its own

## Indications for use
The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.

Source page: https://510kreport.com/device/K990435
Methodology: https://510kreport.com/methodology