510(k) · Cleared
Recalled · 2010Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath
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 Jan 13, 2004 as substantially equivalent to K904788 (Boston Scientific Corp, 1990) and 7 other predicates after a 62-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 13, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 2
- Predicates
- 8
Its longest line of descent runs back 7 generations to K904788 (1990). 20 ancestors in all, the oldest K883880 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 5 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 4 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 3 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 2 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 1 generation backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- This deviceK033569 Flowmedica Bifurcated Infusion System, Infusion Catheter and…Flowmedica, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK082163 Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −6 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −5 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −4 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −3 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −2 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −1 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| 0 (this device) | K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath | Flowmedica, Inc. | 2004 | — |
| +1 | K082163 | Flowmedica Benephit Infusion Systems | Flowmedica, Inc. | 2008 | 6 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (10)
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 |
|---|---|---|---|
| * | K904788 | Mewissen CatheterSummary page 2…: Continuous Flush Catheter Introducer, Catheter PREDICATE DEVICES FlowMedica Bifurcated Infusion Catheter: Boston Scientific MewissenTM Catheter (K904788) T Interventional Innovations Flower M Infusion Catheter (K955525) EKOS Peripheral Infusion Sys… | 1990 |
| * | K955525 | Flower Infusion Catheter Model F-25/50, F-60/70Summary page 2…Bifurcated Infusion Catheter: Boston Scientific MewissenTM Catheter (K904788) T Interventional Innovations Flower M Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen T M Thrombolysis Wire (K883880) Boston Scientific Cragg FXT M… | 1996 |
| * | K030637 | Ekos Peripheral Infusion SystemSummary page 2…ntific MewissenTM Catheter (K904788) T Interventional Innovations Flower M Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen T M Thrombolysis Wire (K883880) Boston Scientific Cragg FXT M Wire (K897152). FlowMedica Introducer Sh… | 2003 |
| * | K883880 | Katzen Thrombolysis GuidewireSummary page 2…T Interventional Innovations Flower M Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen T M Thrombolysis Wire (K883880) Boston Scientific Cragg FXT M Wire (K897152). FlowMedica Introducer Sheath: Cook Check-Flo® Performer® Introducer (unable to de… | 1989 |
| * | K897152 | Cragg Convertible WireSummary page 2…ower M Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen T M Thrombolysis Wire (K883880) Boston Scientific Cragg FXT M Wire (K897152). FlowMedica Introducer Sheath: Cook Check-Flo® Performer® Introducer (unable to determine 51 O[k] reference) Cook Shuttle® SL F… | 1990 |
| * | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro SetSummary page 2…[k] reference) Cook Shuttle® SL Flexor® Tuohy-Borst Side Ann Introducer Set (unable to determine 51 0[k] reference) Super ArTow-Flex® Percutaneous Sheath Introducer Set (K924607, K970229) Terumo PinnacleTM DestinationTM Renal Guiding Sheath (KO 12854) INTENDED USE The FlowMedica Bifurcated Infusion Syste… | 1993 |
| * | K970229 | Arrow Transseptal Super Arrow-Flex Percutaneous SetSummary page 2…ence) Cook Shuttle® SL Flexor® Tuohy-Borst Side Ann Introducer Set (unable to determine 51 0[k] reference) Super ArTow-Flex® Percutaneous Sheath Introducer Set (K924607, K970229) Terumo PinnacleTM DestinationTM Renal Guiding Sheath (KO 12854) INTENDED USE The FlowMedica Bifurcated Infusion System is inte… | 1998 |
| * | K012854 | Renal Guiding Sheath | 2001 |
| * | — | Cook Check-Flo Performer Introducer Named without a submission number | |
| * | — | Cook Shuttle SL Flexor Tuohy-Borst Side Arm Introducer Set Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082163 | Flowmedica Benephit Infusion Systems | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 8 of the 20 ancestors have a recall of any class.
- Of its descendants, K082163 (Flowmedica, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K904788.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033569
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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