# K080657: Neb-90 Large Volume Medication Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Medi Nuclear Corp., Inc.
- Decided: Jun 30, 2008 after 115 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
Longest line of descent: 1 generation back to K915075 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915075: Nebulizer (Direct Patient Interface), Medi Nuclear Corp., Inc. (1992) Summary page 1.
- K980407: Hope Nebulizer, B&B Medical Technologies, Inc. (1998) Summary page 1.
- (no number) Smiths Medical - DHD Health Flo-Mist: named in the summary without a submission number

## Indications for use
The Neb-90TM Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis. The Neb-90TM Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.

Source page: https://510kreport.com/device/K080657
Methodology: https://510kreport.com/methodology