510(k) · Cleared
Recalled · Class II · 2011Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066
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 3, 2003 as substantially equivalent to K010004 (Micro Therapeutics, Inc., 2001) after a 49-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 3, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010004 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010004 Flowrider Flow Directed Micro Catheter, Model 105-5065Micro Therapeutics, Inc. · 2001
- This deviceK024118 Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and…Micro Therapeutics, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK034036 Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 3 of its ownK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 3 generations on · 0 of its ownK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025
- Descendant · 2 generations on · 0 of its ownK202318 Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
Most influential descendants
Showing 5 of 5 · See all- K034036Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc. · 2004 · cites it directly4descendants
- K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc. · 2009 · cites it directly3descendants
- K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021 · 2 generations on1descendant
- K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025 · 3 generations on0descendants
- K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065 | Micro Therapeutics, Inc. | 2001 | — |
| 0 (this device) | K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066 | Micro Therapeutics, Inc. | 2003 | — |
| +1 | K034036 | Marathon Flow Directed Micro Catheter, Model 105-5055 | Micro Therapeutics, Inc. | 2004 | 1 |
| +1 | K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter… | Ev3, Inc. | 2009 | 2 |
| +2 | K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021 | — |
| +3 | K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025 | — |
| +2 | K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065Summary page 1Micro Therapeutics, Inc. Special 51O(k) (modifications to K010004) UltraFlowTMHPC Flow Directed Micro Catheter December 13,2002… | 2001 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2011 | Class II | Z-2471-2012 | Error in labeling | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K034036 (Micro Therapeutics, Inc., 2004) has gone furthest, with 4 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 | — |
What is it indicated for?
The UltraFlowTMHPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary 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/K024118 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024118: Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024118
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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