# Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254171 |
| Device | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) |
| Applicant | Shenzhen Mericonn Technology Co., Ltd. |
| Specialty / panel | Anesthesiology |
| Product code | CAF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-18 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |

## Why this score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254171). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.