PuraCath Firefly Needleless Connector IT (9005)

Q: What is the product code of K251375?

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

FDA 510(k) K251375 · Puracath Medical, Inc.

Substantially Equivalent

510(k) numberK251375

Submission

Device name: PuraCath Firefly Needleless Connector IT (9005)
Applicant: Puracath Medical, Inc.
Newark, CA, US
Received: May 2, 2025
Decision date: February 12, 2026
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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K252543	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional	Amsino International, Inc.	05/04/2026SE
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
K203796	Firefly Needleless ConnectorFPA · Traditional	07/30/2021SE
K151620	Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional	01/20/2016SE

Questions and answers

When was PuraCath Firefly Needleless Connector IT (9005) cleared by the FDA?

PuraCath Firefly Needleless Connector IT (9005) (K251375) received a 510(k) decision of Substantially Equivalent on February 12, 2026, 286 days after the submission was received.

What is the product code of K251375?

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