JLN-23XX Series Piston Compress Nebulizer (Models JLN-2300AS, JLN-2301AS, JLN-2317AS, JLN-2320AS)
by Shenzhen Homed Medical Device Co., Ltd.
510(k) K161586
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK161586 | Date6 Sep 2017 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
- 510(k) Number
- FDA Product Code
- CAF
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The JLN-23XX Series Piston Compress Nebulizer is a piston-driven air compressor device designed for nebulization therapy. It generates compressed air to aerosolize liquid medication into a fine mist for inhalation, facilitating respiratory treatment in home health care settings.
This device is supplied as a reusable, AC-powered unit intended for use in non-clinical environments such as patient homes. Authorized under FDA 510K clearance (K161586) and MDR compliance, it operates as a Class II medical device under the Product Code CAF. No MRI safety or sterility specifications are indicated in the data.
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Questions
AI-generated answers, 18 Sep 2026
What types of environments is the JLN-23XX Series Piston Compress Nebulizer intended for use in?
The JLN-23XX Series is designed for non-clinical settings, specifically patient homes or home health care environments. It is an AC-powered, reusable device and is not intended for use in clinical or hospital settings.
How many models are included in the JLN-23XX Series, and what distinguishes them?
The series includes four models: JLN-2300AS, JLN-2301AS, JLN-2317AS, and JLN-2320AS. While the exact distinctions between these models are not specified in the data, they are all part of the same piston-driven nebulizer line and likely differ in features like airflow settings, control options, or compatibility with accessories.
Is the JLN-23XX Series Piston Compress Nebulizer single-use or reusable, and how is it powered?
The device is reusable and designed for long-term use in home health care. It is AC-powered, meaning it requires a standard electrical outlet for operation, making it suitable for continuous use in residential settings.
What regulatory pathways has the JLN-23XX Series followed for market authorization?
The device has been authorized through FDA 510(k) clearance (K161586) and MDR compliance, classifying it as a Class II medical device under Product Code CAF. This indicates it meets U.S. and EU regulatory standards for safety and performance in its intended use.
Does the JLN-23XX Series have any special handling requirements, such as sterility or MRI safety considerations?
The data does not specify any sterility requirements for the JLN-23XX Series, meaning it is not intended to be sterile and should be cleaned and maintained per manufacturer guidelines. Additionally, there are no MRI safety specifications mentioned, so it should not be used in or near MRI environments.