Sapphire Administration Set

Q: What is the product code of K141834?

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

FDA 510(k) K141834 · Q Core Medical , Ltd.

Substantially Equivalent

510(k) numberK141834

Submission

Device name: Sapphire Administration Set
Applicant: Q Core Medical , Ltd.
Gaithersburg, MD, US
Received: July 7, 2014
Decision date: August 5, 2014
Decision: Substantially Equivalent (SESE)
Type: Special 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

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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

More from B.Braun Medical, Inc.

510(k)	Device	Decision
K192860	Sapphire Infusion Pump, Sapphire administration setsFRN · Traditional	11/19/2020SE
K161667	Sapphire Infusion PumpFRN · Traditional	03/27/2017SE
K141389	Sapphire Infusion PumpFRN · Traditional	12/11/2014SE
K123049	Sapphire Infusion PumpFRN · Traditional	10/17/2013SE

Questions and answers

When was Sapphire Administration Set cleared by the FDA?

Sapphire Administration Set (K141834) received a 510(k) decision of Substantially Equivalent on August 5, 2014, 29 days after the submission was received.

What is the product code of K141834?

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