510(k) · Cleared
ClearedFlowrider Flow Directed Micro Catheter, Model 105-5065
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · KRA Catheter, Continuous Flush
Cleared on Feb 13, 2001 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 13, 2001
- Review
- 42 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK010004 Flowrider Flow Directed Micro Catheter, Model 105-5065Micro Therapeutics, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK024118 Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and…Micro Therapeutics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK034036 Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 4 generations on · 0 of its ownK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K024118Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066Micro Therapeutics, Inc. · 2003 · cites it directly5descendants
- K034036Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc. · 2004 · 2 generations on4descendants
- K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc. · 2009 · 2 generations on3descendants
- K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021 · 3 generations on1descendant
- K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065 | Micro Therapeutics, Inc. | 2001 | — |
| +1 | K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066 | Micro Therapeutics, Inc. | 2003 | 1 |
| +2 | K034036 | Marathon Flow Directed Micro Catheter, Model 105-5055 | Micro Therapeutics, Inc. | 2004 | 1 |
| +2 | K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter… | Ev3, Inc. | 2009 | 2 |
| +3 | K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021 | — |
| +4 | K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066 | 2003 | 5 |
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?
- Of its descendants, K024118 (Micro Therapeutics, Inc., 2003) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K010004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010004: Flowrider Flow Directed Micro Catheter, Model 105-5065.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026