Cleared Traditional

K254171 - Mesh Nebulizer (UN204)

Also marketed or referenced as:
Mesh Nebulizer (UN205) Mesh Nebulizer (UN209) Mesh Nebulizer (UN210)

K254171 is an FDA 510(k) clearance for Mesh Nebulizer (UN204), manufactured by Shenzhen Mericonn Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K254171 · Shenzhen Mericonn Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
269d
Days
Class 2
Risk

K254171 is an FDA 510(k) clearance for the Mesh Nebulizer (UN204). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Shenzhen Mericonn Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 18, 2026 after a review of 269 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Mericonn Technology Co., Ltd. devices

FDA 510(k) Submission Details - K254171

510(k) Number K254171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date September 18, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 140d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Chonconn Consulting Co., Ltd.
Jie Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 407
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