510(k) Report

510(k) · Cleared

Cleared

Echelon Micro Catheter, Model 105-5091

K031992510(k) SpecialCleared Aug 7, 200341-day reviewClass II21 CFR 870.1210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Micro Therapeutics, Inc. · KRA Catheter, Continuous Flush

Cleared on Aug 7, 2003 as substantially equivalent to K030688 (Micro Therapeutics, Inc., 2003) after a 41-day review. Its family tree reaches back 3 generations to 1998. 7 later devices descend from it.

Decided
Aug 7, 2003
Review
41 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K974473 (1998). 7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant clearedK974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 1998K993672 · Rebar Micro Catheter, Models 105-5080, 105-5086 · Micro Therapeutics, Inc. · 2000K030688 · Echelon Micro Catheter, Model 105-5092-150 · Micro Therapeutics, Inc. · 2003 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K030688 · Echelon Micro Catheter, Model 105-5092-150 · Micro Therapeutics, Inc. · 2003 · recalledK993672 · Rebar Micro Catheter, Models 105-5080, 105-5086 · Micro Therapeutics, Inc. · 2000K974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 19980
  1. Root · 3 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
  2. 2 generations backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
  3. 1 generation backK030688 Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · Recalled
  4. This deviceK031992 Echelon Micro Catheter, Model 105-5091Micro Therapeutics, Inc. · 2003
  5. Descendant · cites it directly · 5 of its ownK051990 Echelon Micro CatheterMicro Therapeutics, Inc. · 2006
  6. Descendant · cites it directly · 5 of its ownK042187 Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro…Micro Therapeutics, Inc. · 2004
  7. Descendant · cites it directly · 3 of its ownK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
  9. Descendant · 3 generations on · 0 of its ownK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12009: 22020: 12021: 12025: 1
2004high 2 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K051990Echelon Micro CatheterMicro Therapeutics, Inc. · 2006 · cites it directly5descendants
  • K042187Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon…Micro Therapeutics, Inc. · 2004 · cites it directly5descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K974473Easy Rider Micro CatheterMicro Therapeutics, Inc.1998—
−2K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc.2000—
−1K030688Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc.20032
0 (this device)K031992Echelon Micro Catheter, Model 105-5091Micro Therapeutics, Inc.2003—
+1K051990Echelon Micro CatheterMicro Therapeutics, Inc.2006—
+1K042187Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter…Micro Therapeutics, Inc.2004—
+1K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter…Ev3, Inc.20092
+2K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular2021—
+3K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200920
202010
202110
202510
FIG. 1 — Lineage of K031992, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030688Echelon Micro Catheter, Model 105-5092-150
Summary page 1
Micro Therapeutics, Inc. Special 510(k) (modification to K030688) Echelonm Micro Catheter June 26,2003 AUG - 7 2003 4.…
Micro Therapeutics, Inc.20032

Also cleared against K030688: 5 other devices →

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051990Echelon Micro CatheterMicro Therapeutics, Inc.20065
K042187Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon…Micro Therapeutics, Inc.20045
K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc.20093
K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…Micro Therapeutics, Inc.20090

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 5 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K051990 (Micro Therapeutics, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 5 other devices also cite its predicate K030688.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 29 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KRA

41so far in 2026, the most since 2007

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
2007high 41 (2026) · low 0 (2017)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KRA

980in 2025

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

What is it indicated for?

The Echelon 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.

Also cleared against K030688

5 other devices cite the same predicate.

  • K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro…Ev3, Inc. · 20092 recalls
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K051990Echelon Micro CatheterMicro Therapeutics, Inc. · 2006
  • K042187Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro…Micro Therapeutics, Inc. · 2004
  • K034036Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc. · 20041 recall

More from Micro Therapeutics, Inc.

51 FDA decisions under this applicant name. See the company

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K031992 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031992: Echelon Micro Catheter, Model 105-5091.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031992

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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