510(k) · Cleared
ClearedProwler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · KRA Catheter, Continuous Flush
Cleared on Mar 27, 2002 as substantially equivalent to K965181 (Cordis Neurovascular, Inc., 1997) and 3 other predicates after a 23-day review. Its family tree reaches back 2 generations to 1995. 35 later devices descend from it.
- Decided
- Mar 27, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K945904 (1995). 6 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 1 generation backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- This deviceK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
- Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- Descendant · cites it directly · 16 of its ownK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
- K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
- K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002 · cites it directly16descendants
- K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 3 generations on9descendants
- K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc. · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −1 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| 0 (this device) | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| +1 | K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | Kerberos Proximal Solutions, Inc. | 2004 | — |
| +2 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| +1 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| +3 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| +2 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K965181 | Ces Infusion CatheterSummary page 2…t page KOZ0630 PZ('L_ Summary of Safety and Effectiveness, Continued 0-00002 | Predicate Devices The predicate devices are listed in the table below: K965181 74KRA Infusion Catheters Inc. with pre-shaped tips PROWLER Cord1s,1(\Ieurc;‘v!ascular, Infusion Catheters Inc. K972518 PROWL… | 1997 |
| * | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion CatheterSummary page 2…dicate devices are listed in the table below: K965181 74KRA Infusion Catheters Inc. with pre-shaped tips PROWLER Cord1s,1(\Ieurc;‘v!ascular, Infusion Catheters Inc. K972518 PROWLER® PLUS | Cordis Neurovascular, | K993266 74KRA Infusion Catheters Inc. PROWLER® Cordis Neurovascular, | K003925 7T4KRA… | 1997 |
| * | K993266 | Prowler Plus Infusion CatheterSummary page 2…65181 74KRA Infusion Catheters Inc. with pre-shaped tips PROWLER Cord1s,1(\Ieurc;‘v!ascular, Infusion Catheters Inc. K972518 PROWLER® PLUS | Cordis Neurovascular, | K993266 74KRA Infusion Catheters Inc. PROWLER® Cordis Neurovascular, | K003925 7T4KRA Summary of Studies Summary of Substantial Equiva… | 1999 |
| * | K003925 | Prowler Infusion Catheters with Pre-Shaped TipsSummary page 2…1s,1(\Ieurc;‘v!ascular, Infusion Catheters Inc. K972518 PROWLER® PLUS | Cordis Neurovascular, | K993266 74KRA Infusion Catheters Inc. PROWLER® Cordis Neurovascular, | K003925 7T4KRA Summary of Studies Summary of Substantial Equivalence Design verification testing showed that the PROWLER® SELECT™ 10 a… | 2001 |
What descends from it? (35)
See all 352 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K041123 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K965181.
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?
The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020680: Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020680
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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