Huber Needle Sets

Q: When was Huber Needle Sets cleared by the FDA?

Huber Needle Sets (K933898) received a 510(k) decision of Substantially Equivalent on September 27, 1995, 778 days after the submission was received.

Q: What is the product code of K933898?

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

FDA 510(k) K933898 · Mediziv Medical Products 1987 , Ltd.

Substantially Equivalent

510(k) numberK933898

Submission

Device name: Huber Needle Sets
Applicant: Mediziv Medical Products 1987 , Ltd.
Tel Aviv, IL
Received: August 10, 1993
Decision date: September 27, 1995
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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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

More from B.Braun Medical, Inc.

510(k)	Device	Decision
K933524	Extention SetFPK · Traditional	05/23/1995SE
K933523	I.V. Filter SetFPB · Traditional	05/19/1995SE
K933522	Introducer Needle (Several Sizes)DYB · Traditional	02/21/1995SE

Questions and answers

When was Huber Needle Sets cleared by the FDA?

Huber Needle Sets (K933898) received a 510(k) decision of Substantially Equivalent on September 27, 1995, 778 days after the submission was received.

What is the product code of K933898?

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