Compressor Nebulizer System, Model KN-9321
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K051365
Overview
The Compressor Nebulizer System, Model KN-9321, is a piston-type compressor device designed to generate compressed air for use with a nebulizer. It falls under the classification of a compressor-driven nebulizer system, delivering aerosolized medication via inhalation therapy for respiratory conditions.
This system is intended for home health care use and operates using either AC power via a universal adapter or DC power. It is classified as substantially equivalent under FDA 510(k) clearance (K051365) and is not described as single-use or sterile. The device is portable, lightweight, and intended for convenience in delivering compressed air to a nebulizer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051365 | Date22 Jul 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 respiratory conditions is this compressor nebulizer system designed to help manage?
The KN-9321 Compressor Nebulizer System is designed to deliver aerosolized medication via inhalation therapy for respiratory conditions. While the exact conditions aren’t specified, it is intended for use in home health care settings to provide compressed air to a nebulizer, which is commonly used for treating conditions like asthma, COPD, or other respiratory ailments requiring inhaled medications.
How is the KN-9321 powered, and is it portable for use outside a fixed location?
The KN-9321 operates using either AC power through a universal adapter or DC power, making it versatile for different settings. It is also described as portable and lightweight, which suggests it can be moved easily for use outside a fixed location, such as at home or in travel-friendly environments.
Is the KN-9321 system single-use, or can it be reused after cleaning?
The KN-9321 is not described as single-use, meaning it is intended for reuse after proper cleaning and maintenance. However, the device itself is not sterile, so it must be cleaned and disinfected according to manufacturer guidelines to ensure safe and effective use over multiple treatments.
What regulatory pathway was followed for FDA clearance of this device, and who is the applicant?
The KN-9321 received FDA clearance through an abbreviated 510(k) process, classified as substantially equivalent to a predicate device. The applicant for this clearance was K-Jump Health Co., Ltd., and the review was conducted by the FDA’s Anesthesiology (AN) Advisory Committee. The clearance number assigned is K051365.