# K082163: Flowmedica Benephit Infusion Systems

- Pathway: 510(k) (Traditional)
- Applicant: Flowmedica, Inc.
- Decided: Oct 29, 2008 after 90 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904788 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath, Flowmedica, Inc. (2004) Summary page 2.
- K050205: Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath, Flowmedica, Inc. (2005) Summary page 2.

## Recalls of this device
- Feb 6, 2012 · Not classified · Z-1114-2012: The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
- Feb 6, 2012 · Not classified · Z-1113-2012: The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
- Feb 6, 2012 · Not classified · Z-1112-2012: The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
- Dec 5, 2011 · Not classified · Z-0509-2012: The Benephit XT Infusion System may contain hairline cracks in the sheath hub.
- Apr 30, 2010 · Not classified · Z-1734-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod
- Apr 30, 2010 · Not classified · Z-1733-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod

## Indications for use
The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit®Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.

Source page: https://510kreport.com/device/K082163
Methodology: https://510kreport.com/methodology