Cleared Traditional

Disposable Infusion Bag for Parenteral Nutrition

K222622 · Beijing L&Z Medical Technology Development Co., Ltd. · General Hospital

Feb 2023

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K222622 is an FDA 510(k) clearance for the Disposable Infusion Bag for Parenteral Nutrition, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Beijing L&Z Medical Technology Development Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 16, 2023, 169 days after receiving the submission on August 31, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number	K222622 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2022
Decision Date	February 16, 2023
Days to Decision	169 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF