Disposable Infusion Bag for Parenteral Nutrition

Q: What is the product code of K252079?

The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.

FDA 510(k) K252079 · Beijing L&Z Medical Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK252079

Submission

Device name: Disposable Infusion Bag for Parenteral Nutrition
Applicant: Beijing L&Z Medical Technology Development Co., Ltd.
Beijing, CN
Received: July 2, 2025
Decision date: April 2, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KPE – Container, I.V.
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5025
Specialty: General Hospital

Other 510(k)s with product code KPE

510(k)	Device	Applicant	Decision
K251980	ClaveQS BagKPE · Traditional	Icu Medical, Inc.	03/20/2026SE
K251139	KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional	Fresenius Kabi AG	01/09/2026SE
K252094	eZSURE Empty Fluid ContainerKPE · Special	Epic Medical Pte. , Ltd.	08/01/2025SE
K250459	DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional	Technoflex Sas.	04/18/2025SE
K241442	eZSURE Empty Fluid Container with ProSeal Injection SiteKPE · Special	Epic Medical Pte. , Ltd.	06/21/2024SE
K223674	eZSURE Empty Fluid Container (models 426030, 426040, 426110)KPE · Traditional	Epic Medical Pte. , Ltd.	09/01/2023SE
K222622	Disposable Infusion Bag for Parenteral NutritionKPE · Traditional	Beijing L&Z Medical Technology Development Co.…	02/16/2023SE
K210749	Empty EVA BagKPE · Traditional	Haemotronic S.P.A.	08/19/2021SE
K201936	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional	Gilero, LLC	05/06/2021SE
K193528	Empty EVA BagKPE · Traditional	Haemotronic S.P.A.	07/22/2020SE

More from Haemotronic S.P.A.

510(k)	Device	Decision
K240052	Disposable Enteral Feeding SetsPIF · Traditional	07/03/2024SE
K222622	Disposable Infusion Bag for Parenteral NutritionKPE · Traditional	02/16/2023SE

Questions and answers

When was Disposable Infusion Bag for Parenteral Nutrition cleared by the FDA?

Disposable Infusion Bag for Parenteral Nutrition (K252079) received a 510(k) decision of Substantially Equivalent on April 2, 2026, 274 days after the submission was received.

What is the product code of K252079?

The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.