Mesh Nebulizer (4 models)— 510(k) K254171
Substantially EquivalentShenzhen Mericonn Technology Co., Ltd.
FDA 510(k) clearance K254171 for Mesh Nebulizer (4 models), Substantially Equivalent on 2026-09-18. Applicant: Shenzhen Mericonn Technology Co., Ltd.. Device class: 2.
Summary
This Mesh Nebulizer submission covers four models: UN204, UN205, UN209, and UN210. Shenzhen Mericonn Technology Co., Ltd. filed it under product code CAF (Nebulizer (Direct Patient Interface)). The record doesn't say how the models differ.
Class II, 21 CFR 868.5630. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Mericonn filed from Shenzhen, China. The decision came 269 calendar days after FDA received it (December 23, 2025 to September 18, 2026).
Clearance details
- Device name as filed
- Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
- Applicant
- Shenzhen Mericonn Technology Co., Ltd.
- Product code
- Product code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code CAF
view allMore clearances from Shenzhen Mericonn Technology Co., Ltd.
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.