# K980407: Hope Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: B&B Medical Technologies, Inc.
- Decided: May 27, 1998 after 113 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K040718: TRUST (2004), 2 descendants of its own
- K080230: Neb-U-Mask System, Models 1895, 1896 (2008), 1 descendant of its own
- K130379: Rollins 7 Oxygen Mask (2013), 0 descendants of its own
- K080657: Neb-90 Large Volume Medication Nebulizer (2008), 0 descendants of its own

## Indications for use
qnig device is to be used under medical supervision in hospitals nusring homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used tc deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions fcr patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The hope requires 50 psig source gas. He, air or oxygen may be added via Multi-gas inlet.

Source page: https://510kreport.com/device/K980407
Methodology: https://510kreport.com/methodology