510(k) · Cleared
ClearedMicro Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Zenith Vascular SciTech Limited · KRA Catheter, Continuous Flush
Cleared on Jul 30, 2025 as substantially equivalent to K210114 (Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular, 2021) after a 257-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Jul 30, 2025
- Review
- 257 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K974473 (1998). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
- 6 generations backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
- 5 generations backK030688 Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · Recalled
- 4 generations backK031992 Echelon Micro Catheter, Model 105-5091Micro Therapeutics, Inc. · 2003
- 3 generations backK042187 Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro…Micro Therapeutics, Inc. · 2004
- 2 generations backK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009 · Recalled
- 1 generation backK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
- This deviceK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K974473 | Easy Rider Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
| −6 | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000 | — |
| −5 | K030688 | Echelon Micro Catheter, Model 105-5092-150 | Micro Therapeutics, Inc. | 2003 | 2 |
| −4 | K031992 | Echelon Micro Catheter, Model 105-5091 | Micro Therapeutics, Inc. | 2003 | — |
| −3 | K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter… | Micro Therapeutics, Inc. | 2004 | — |
| −2 | K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter… | Ev3, Inc. | 2009 | 2 |
| −1 | K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021 | — |
| 0 (this device) | K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 14.4 · 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? (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 |
|---|---|---|---|
| * | K210114 | Rebar Micro CatheterSummary page 5…Product Code KRA QJP Device Classification Class II Predicate Device RebarTM Micro Catheter (K210114) Device Description The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The M… | 2021 |
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 27 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243534: Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243534
Report an extraction error
Are you the manufacturer?
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