510(k) · Cleared
ClearedEchelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro Catheter,90
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 Sep 2, 2004 as substantially equivalent to K030688 (Micro Therapeutics, Inc., 2003) and 1 other predicate after a 21-day review. Its family tree reaches back 4 generations to 1998. 5 later devices descend from it.
- Decided
- Sep 2, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974473 (1998). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
- 3 generations backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
- 2 generations backK030688 Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · Recalled
- 1 generation backK031992 Echelon Micro Catheter, Model 105-5091Micro Therapeutics, Inc. · 2003
- This deviceK042187 Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro…Micro Therapeutics, Inc. · 2004
- 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
- Descendant · cites it directly · 0 of its ownK090870 Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and…Micro Therapeutics, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- 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
- K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…Micro Therapeutics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974473 | Easy Rider Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
| −3 | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000 | — |
| −2 | K030688 | Echelon Micro Catheter, Model 105-5092-150 | Micro Therapeutics, Inc. | 2003 | 2 |
| −1 | K031992 | Echelon Micro Catheter, Model 105-5091 | Micro Therapeutics, Inc. | 2003 | — |
| 0 (this device) | K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter… | Micro Therapeutics, Inc. | 2004 | — |
| +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 | — |
| +1 | K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and… | Micro Therapeutics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K030688 | Echelon Micro Catheter, Model 105-5092-150Summary page 1K.o4Z I Micro Therapeutics, Inc. Special 510(k) (modification to K030688 and K031992) Tip-Shape EchelonTM Micro Catheter August 6, 2004 SEP - 2 2004 4. 510(k) S… | 2003 |
| * | K031992 | Echelon Micro Catheter, Model 105-5091Summary page 1…= Page 1 === K.o4Z I Micro Therapeutics, Inc. Special 510(k) (modification to K030688 and K031992) Tip-Shape EchelonTM Micro Catheter August 6, 2004 SEP - 2 2004 4. 510(k) Summary TRAD… | 2003 |
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)
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 6 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093750 (Ev3, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K030688.
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 Tip-Shape Echelon TM Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042187: Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro Catheter,90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042187
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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