PVC Free Intravascular Administration Set

Q: What is the product code of K011216?

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

FDA 510(k) K011216 · Biometrix , Ltd.

Substantially Equivalent

510(k) numberK011216

Submission

Device name: PVC Free Intravascular Administration Set
Applicant: Biometrix , Ltd.
Jerusalem, IL
Received: April 20, 2001
Decision date: July 18, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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

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Questions and answers

When was PVC Free Intravascular Administration Set cleared by the FDA?

PVC Free Intravascular Administration Set (K011216) received a 510(k) decision of Substantially Equivalent on July 18, 2001, 89 days after the submission was received.

What is the product code of K011216?

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