Cleared Traditional

Breathing circuit bacterial/viral filter

K222917 · Shaoxing Haitech Medical Products Co., Ltd. · General Hospital

Feb 2024

Decision

507d

Days

Class 2

Risk

About This 510(k) Submission

K222917 is an FDA 510(k) clearance for the Breathing circuit bacterial/viral filter, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Shaoxing Haitech Medical Products Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on February 15, 2024, 507 days after receiving the submission on September 26, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K222917 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2022
Decision Date	February 15, 2024
Days to Decision	507 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement