Needle Free Connector

Q: What is the product code of K213004?

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

FDA 510(k) K213004 · Medcaptain Life Science Co., Ltd.

Substantially Equivalent

510(k) numberK213004

Submission

Device name: Needle Free Connector
Applicant: Medcaptain Life Science Co., Ltd.
Shenzhen, CN
Received: September 20, 2021
Decision date: May 10, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 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

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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

More from B.Braun Medical, Inc.

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K202619	KardiFlex PTCA Balloon Dilatation CatheterLOX · Traditional	04/29/2021SE
K202748	Enteral Feeding CatheterKNT · Traditional	04/09/2021SE

Questions and answers

When was Needle Free Connector cleared by the FDA?

Needle Free Connector (K213004) received a 510(k) decision of Substantially Equivalent on May 10, 2022, 232 days after the submission was received.

What is the product code of K213004?

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