Cleared Traditional

AllNEB

K242354 · Enchant Tek Co. , Ltd. · Anesthesiology

Apr 2025

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K242354 is an FDA 510(k) clearance for the AllNEB, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Enchant Tek Co. , Ltd. (Yilan County, TW). The FDA issued a Cleared decision on April 29, 2025, 264 days after receiving the submission on August 8, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K242354 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2024
Decision Date	April 29, 2025
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF