510(k) · Cleared
ClearedProwler Select Plus; Prowler EX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · KRA Catheter, Continuous Flush
Cleared on Aug 25, 2021 as substantially equivalent to K021591 (Cordis Neurovascular, Inc., 2002) after a 156-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 25, 2021
- Review
- 156 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945904 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 3 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 2 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- 1 generation backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- This deviceK210838 Prowler Select Plus; Prowler EXMedos International SARL · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −3 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −2 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| −1 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| 0 (this device) | K210838 | Prowler Select Plus; Prowler EX | Medos International SARL | 2021 | — |
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 |
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 14.5 · 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? (1)
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 |
|---|---|---|---|
| * | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsSummary page 4…PROWLER SELECT (10, 14, Predicate AND PLUS) INFUSION K021591 22 May 2002 CATHETERS WITH AND… | 2002 |
| † | K162563 | YOGA Microcatheter | 2017 |
| † | K191237 | CERENOVUS Large Bore Catheter | 2019 |
| † | K131437 | Modified Concentric Microcatheter | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K021591.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.
The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.
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/K210838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210838: Prowler Select Plus; Prowler EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210838
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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