510(k) · Cleared
ClearedSwiftNINJA Steerable Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on Jul 16, 2021 as substantially equivalent to K161921 (Merit Medical Systems, Inc., 2016) after a 60-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jul 16, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960806 (1996). 13 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 7 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 6 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 5 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 4 generations backK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
- 3 generations backK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
- 2 generations backK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
- 1 generation backK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- This deviceK211525 SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −7 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −6 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −5 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −4 | K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00… | Micrus Endovascular Corporation | 2006 | — |
| −3 | K070456 | Micrus Courier Enzo Microcatheter 0.017 | Micrus Endovascular Corporation | 2007 | — |
| −2 | K072526 | Micrus Courier Enzo Microcatheter 0.0190 | Micrus Endovascular Corporation | 2007 | — |
| −1 | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| 0 (this device) | K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K161921 | SwiftNINJA MicrocatheterSummary page 4…Name: SwiftNINJA Steerable Microcatheter Classification Name: Continuous Flush Catheter Predicate Premarket Notification: K161921 Device Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to… | 2016 |
| † | K070456 | Micrus Courier Enzo Microcatheter 0.017 | 2007 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161921.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature. The catheter should not be used in the cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211525: SwiftNINJA Steerable Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211525
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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