510(k) · Cleared
Recalled · 2012Flowmedica Benephit Infusion Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flowmedica, Inc. · KRA Catheter, Continuous Flush
Cleared on Oct 29, 2008 as substantially equivalent to K033569 (Flowmedica, Inc., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1990. It has been recalled 6 times.
- Decided
- Oct 29, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 8 generations to K904788 (1990). 22 ancestors in all, the oldest K883880 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 7 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 6 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 5 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 4 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 3 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 2 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 1 generation backK033569 Flowmedica Bifurcated Infusion System, Infusion Catheter and…Flowmedica, Inc. · 2004 · Recalled
- This deviceK082163 Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −7 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −6 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −5 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −4 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −3 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −2 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −1 | K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath | Flowmedica, Inc. | 2004 | 2 |
| 0 (this device) | K082163 | Flowmedica Benephit Infusion Systems | Flowmedica, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathSummary page 2…FlowMedica BenephitO Infusion Systems, each being a legally marketed device per 21 CFR 807.92(a)(3), serve as their own predicates. Reference original 510(k) submissions K033569 (cleared January 13, 2004) and K050205 (cleared March 4, 2005). INTENDED USE The FlowMedica Benephit® Infusion Systems are inten… | 2004 |
| * | K050205 | Benephit Bifurcated Infusion Catheter and 5FR. Introducer SheathSummary page 2…each being a legally marketed device per 21 CFR 807.92(a)(3), serve as their own predicates. Reference original 510(k) submissions K033569 (cleared January 13, 2004) and K050205 (cleared March 4, 2005). INTENDED USE The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therap… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2012 | Not classified | Z-1114-2012 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | The Benephit XT Infusion System may contain hairline cracks in the sheath hub. |
| Apr 30, 2010 | Not classified | Z-1734-2010 | Packaging change control | 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 product, which could potentially cause a… |
| Apr 30, 2010 | Not classified | Z-1733-2010 | Packaging change control | 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 product, which could potentially cause a… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 10 of the 22 ancestors have a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082163: Flowmedica Benephit Infusion Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082163
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026