Ecomed Disposable Administration Sets

Q: What is the product code of K254123?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.

FDA 510(k) K254123 · Ecomed Solutions, LLC

Substantially Equivalent

510(k) numberK254123

Submission

Device name: Ecomed Disposable Administration Sets
Applicant: Ecomed Solutions, LLC
Lindenhurst, IL, US
Received: December 19, 2025
Decision date: September 11, 2026
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FPA – Set, Administration, Intravascular
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5440
Specialty: General Hospital

Other 510(k)s with product code FPA

510(k)	Device	Applicant	Decision
K261530	iiSure Infusion SetFPA · Special	Deka Research and Development	06/03/2026SE
K252543	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional	Amsino International, Inc.	05/04/2026SE
K251375	PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional	Puracath Medical, Inc.	02/12/2026SE
K251257	nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional	Np Medical	12/04/2025SE
K250325	BD Alaris Pump Infusion SetFPA · Traditional	Carefusion (Bd)	10/30/2025SE
K251814	EZ IV Administration SetFPA · Traditional	Epic Medical Pte. , Ltd.	08/29/2025SE
K251854	SteadiSet infusion setFPA · Abbreviated	Tandem Diabetes Care	08/06/2025SE
K243841	Sparta Infusion Set for InsulinFPA · Traditional	Deka Research and Development	08/01/2025SE
K243392	Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional	B.Braun Medical, Inc.	07/24/2025SE
K250616	Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional	Icu Medical, Inc.	06/05/2025SE

More from Icu Medical, Inc.

510(k)	Device	Decision
K234129	Ecomed Disposable Administration SetsFPA · Traditional	09/20/2024SE
K162088	Ecomed Disposable Angiographic SyringesDXT · Traditional	01/27/2017SE

Questions and answers

When was Ecomed Disposable Administration Sets cleared by the FDA?

Ecomed Disposable Administration Sets (K254123) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 266 days after the submission was received.

What is the product code of K254123?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.