← Back to catalogue

Hope Nebulizer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980407

by B&B Medical Technologies, Inc.

Identifiers

510(k) Number
K980407 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hope Nebulizer is a large-volume, continuous medication nebulizer designed for aerosol therapy in adult and pediatric patients. It delivers high-output nebulization for the administration of respiratory medications, including treatments for moderate to severe asthma and chronic obstructive pulmonary disease (COPD).

This refillable, closed-system device is supplied as part of a kit, including an adult aerosol mask and 6-foot tubing. It operates as a single-use device per manufacturer specifications and is intended for use in clinical or home settings. The device holds a FDA 510(k) clearance under product code CAF and is classified under the Anesthesiology advisory committee.

Frequently asked questions

What types of respiratory medications can the Hope Nebulizer deliver, and is it suitable for both adults and children?

The Hope Nebulizer is designed to deliver aerosolized respiratory medications for adult and pediatric patients, including treatments for moderate to severe asthma and chronic obstructive pulmonary disease (COPD). As a large-volume, continuous nebulizer, it provides high-output aerosolization, making it versatile for various respiratory therapies in both clinical and home settings.

Is the Hope Nebulizer intended for single-use or reusable applications, and what does that mean for maintenance?

The Hope Nebulizer is intended for single-use per manufacturer specifications, meaning it should not be reused after one treatment session. This design reduces the risk of contamination and ensures consistent performance. Since it’s a closed-system device, no additional cleaning or maintenance is required beyond proper disposal after use.

What components are included in the Hope Nebulizer kit, and how is it typically used in a treatment setting?

The Hope Nebulizer is supplied as a complete kit, including an adult aerosol mask and 6-foot tubing for connecting to the device. This setup allows for flexible use in both clinical and home environments, enabling continuous aerosol therapy for patients. The mask ensures proper medication delivery to the respiratory tract.

How was the Hope Nebulizer approved by the FDA, and what does its classification under the Anesthesiology advisory committee mean?

The Hope Nebulizer holds FDA 510(k) clearance under product code CAF, classified under the Anesthesiology advisory committee (AN). This means it was determined to be substantially equivalent to a legally marketed device already on the market, following a traditional review process. The classification reflects its role in respiratory therapy, though it is not intended for anesthesia.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HOPE™ Nebulizer - B&B Medical Technologies, HOPE™ Nebulizer Adult Kit - B&B Medical Technologies, PDF HOPE Nebulizer - Medline, HOPE™ Nebulizer - B&B Medical Technologies, B&B Medical Technologies Hope Nebulizer - Hope Nebulizer with 200 mL ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
B&B Medical Technologies, Inc.

Sources (1)

  • FDA 510(k) K980407 24 fields · synced Sep 19, 2026