Ultrasonic Nebulizer (Mesh Type)
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K121520
Overview
This device is a mesh-type ultrasonic nebulizer, classified under product code CAF (21 CFR 868.5630). It converts liquid medications into a fine aerosol mist for inhalation therapy, suitable for both adult and pediatric patients. The mesh nebulizer technology ensures efficient aerosol generation with minimal heat, preserving medication integrity.
The Ultrasonic Nebulizer (Mesh Type) is designed for use in home, hospital, or clinical settings to deliver respiratory treatments. It operates as a portable, battery-powered device and is intended for single-use applications, though reuse may be possible if manufacturer guidelines are followed. The device holds an FDA 510(k) clearance (K121520) under an abbreviated review process, with no third-party involvement. No additional regulatory markings or sterility claims are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121520 | Date15 Mar 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from K-jump Health Co., Ltd.
Questions
What types of patients can use this mesh-type ultrasonic nebulizer, and how is it different from other nebulizers?
This device is designed for both adult and pediatric patients, making it versatile for home, hospital, or clinical use. Unlike traditional ultrasonic nebulizers, the mesh-type technology ensures more efficient aerosol generation with minimal heat, which helps preserve the integrity of the medication. This is particularly useful for treatments requiring precise dosing or sensitive medications.
Is this nebulizer intended for single-use only, or can it be reused if cleaned properly?
The manufacturer specifies that this device is designed for single-use applications, though the documentation notes that reuse *may* be possible if strict manufacturer guidelines are followed. Since no explicit sterility claims are provided, proper cleaning and maintenance would be required if reuse is pursued, but this is not officially endorsed by the manufacturer.
How is this device powered, and is it suitable for portable use outside of a clinical setting?
Yes, this nebulizer is explicitly designed as a portable, battery-powered device, making it ideal for home use or on-the-go treatments. Its compact and likely lightweight design (implied by its classification and intended use) would allow for easy transport, though specific battery life or weight details are not provided in the data.
What regulatory pathway was followed for FDA clearance, and does this device involve any third-party review?
This device received FDA clearance through an abbreviated 510(k) review process (K121520) under product code CAF, classified under 21 CFR 868.5630. The review was conducted by the Anesthesiology (AN) Advisory Committee, and there was no third-party involvement in the clearance process. The decision was based on substantial equivalence to a predicate device.
Are there any specific storage requirements mentioned for this nebulizer?
The provided data does not explicitly detail storage requirements such as temperature ranges, humidity conditions, or shelf-life specifications. Since it is intended for single-use (or potential reuse under guidelines), proper handling and storage in a clean, dry environment would be recommended to maintain functionality, though no formal sterility claims are made.