Retrograde Infusion Set 3ML & 6ML-

Q: What is the product code of K840443?

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

FDA 510(k) K840443 · Tico Medical Instruments, Inc.

Substantially Equivalent

510(k) numberK840443

Submission

Device name: Retrograde Infusion Set 3ML & 6ML-
Applicant: Tico Medical Instruments, Inc.
Mchenry, IL, US
Received: February 1, 1984
Decision date: April 17, 1984
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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

510(k)	Device	Applicant	Decision
K254123	Ecomed Disposable Administration SetsFPA · Abbreviated	Ecomed Solutions, LLC	09/11/2026SE
K261530	iiSure Infusion SetFPA · Special	Deka Research and Development	06/03/2026SE
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
K911658	Dialysis Trandsducer ProtectorFIB · Traditional	08/12/1991SE
K884938	Vital Signs MonitorDSK · Traditional	04/19/1989SE
K842985	T- Extension Set T-04-CFPA · Traditional	08/07/1984SE

Questions and answers

When was Retrograde Infusion Set 3ML & 6ML- cleared by the FDA?

Retrograde Infusion Set 3ML & 6ML- (K840443) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 76 days after the submission was received.

What is the product code of K840443?

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