Cleared Traditional

Filter and HME/Filter

K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · General Hospital

Feb 2023

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K221472 is an FDA 510(k) clearance for the Filter and HME/Filter, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Ningbo Huakun Medical Equipment Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on February 8, 2023, 264 days after receiving the submission on May 20, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K221472 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2022
Decision Date	February 08, 2023
Days to Decision	264 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement