# K030396: Omni~Neb; Omni~Max

- Pathway: 510(k) (Traditional)
- Applicant: B&B Medical Technologies, Inc.
- Decided: May 7, 2004 after 456 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
Omni-Neb TM This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The Omni~Nebtm Nebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Nebtm requires 45-55 psig source gas of Oxygen or Air. Omni~MaxT m This device is to be used under medical supervision in hospitals. The Omni-Maxr m Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to spontaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max t " requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.

Source page: https://510kreport.com/device/K030396
Methodology: https://510kreport.com/methodology