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Hope Continuous Nebulizer (Hope-11310 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122857

by Pegasus Research Corp.

Identifiers

510(k) Number
K122857 FDA 510(k)
FDA Product Code
CAF FDA 510(k)
Models / Variants
Hope-11310 FDA 510(k)
Heart Nebulizer Model Heart-100609 FDA 510(k)
Theramist Nebulizer Model Theramist-3100 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 Continuous Nebulizer, Heart Nebulizer, and Theramist Nebulizer are medical devices designed to administer therapeutic solutions to the lower respiratory tract of patients. These nebulizers efficiently deliver medication through continuous therapy, featuring quick connections to flowmeters and twist-off reservoirs for easy medication changes. They include standard auxiliary ports for delivery of therapeutic gases and come with prepackaged kits containing necessary accessories.

The devices are supplied as prepackaged kits with needed accessories and include a dosing chart with each unit. They are intended for use in medical settings where continuous medication therapy is required. The devices have received FDA 510(k) clearance with the product code CAF and were reviewed by the Anesthesiology advisory committee.

Frequently asked questions

What is the purpose of the Hope Continuous Nebulizer?

The Hope Continuous Nebulizer is designed to administer therapeutic solutions to the lower respiratory tract of patients through continuous therapy, making it suitable for medical settings requiring continuous medication administration.

What accessories are included with the nebulizer?

The device is supplied as a prepackaged kit containing necessary accessories and includes a dosing chart with each unit to assist with proper medication administration.

How is the nebulizer connected to other equipment?

The nebulizers feature quick connections to flowmeters and include standard auxiliary ports for the delivery of therapeutic gases, allowing for flexible integration in medical settings.

What is the regulatory status of these nebulizers?

The devices have received FDA 510(k) clearance with product code CAF and were reviewed by the Anesthesiology advisory committee, indicating they meet regulatory requirements for medical use.

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 Continuous Nebulizer Model Hope-11310, Heart Nebulizer Model Heart ..., Hope Continuous Nebulizer Model Hope-11310 Heart Nebulizer Model Heart ..., HOPE™ Nebulizer Kits | Tri-anim

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pegasus Research Corp.

Sources (1)

  • FDA 510(k) K122857 24 fields · synced Sep 22, 2026