Chartermed Tpn-Eva Bags

Q: What is the product code of K973103?

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

FDA 510(k) K973103 · Chartermed, Inc.

Substantially Equivalent

510(k) numberK973103

Submission

Device name: Chartermed Tpn-Eva Bags
Applicant: Chartermed, Inc.
Lakewood, NJ, US
Received: August 19, 1997
Decision date: November 24, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

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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

More from Gilero, LLC

510(k)	Device	Decision
K902079	Admixture Container for Total Parenteral NutritionKPE · Traditional	10/29/1990SE
K902464	Chartermed Empty TPN Container - 100 ML CapacityKPE · Traditional	08/30/1990SE
K901753	600 or 1200 Ml. Enteral Bag Administration SetKNT · Traditional	06/01/1990SE

Questions and answers

When was Chartermed Tpn-Eva Bags cleared by the FDA?

Chartermed Tpn-Eva Bags (K973103) received a 510(k) decision of Substantially Equivalent on November 24, 1997, 97 days after the submission was received.

What is the product code of K973103?

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