510(k) · Cleared
ClearedSwiftNINJA 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 Nov 4, 2016 as substantially equivalent to K082613 (Merit Medical Systems, Inc., 2008) and 2 other predicates after a 114-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 4, 2016
- Review
- 114 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K960806 (1996). 12 ancestors in all, the oldest K925813 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 5 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 4 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 3 generations backK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
- 2 generations backK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
- 1 generation backK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
- This deviceK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK211110 Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211525 SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019 · cites it directly2descendants
- K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020 · 2 generations on1descendant
- K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022 · cites it directly0descendants
- K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −6 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −5 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −4 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −3 | K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00… | Micrus Endovascular Corporation | 2006 | — |
| −2 | K070456 | Micrus Courier Enzo Microcatheter 0.017 | Micrus Endovascular Corporation | 2007 | — |
| −1 | K072526 | Micrus Courier Enzo Microcatheter 0.0190 | Micrus Endovascular Corporation | 2007 | — |
| 0 (this device) | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| +1 | K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019 | — |
| +2 | K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020 | — |
| +1 | K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K082613 | Merit MicrocatheterSummary page 4…Trade Name: Merit Microcatheter Classification Name: Continuous Flush Catheter Primary Premarket Notification: K082613 Predicate Manufacturer: Merit Medical Systems, Inc. Device This predicate has… | 2008 |
| * | K072526 | Micrus Courier Enzo Microcatheter 0.0190Summary page 4…Micrus® Courier Enzo™ Microcatheter Predicate Classification Name: Diagnostic intravascular catheter Device Premarket Notification: K072526, K070456 Manufacturer: Micrus Endovascular Corporation The SwiftNINJA®… | 2007 |
| * | K070456 | Micrus Courier Enzo Microcatheter 0.017Summary page 4…rus® Courier Enzo™ Microcatheter Predicate Classification Name: Diagnostic intravascular catheter Device Premarket Notification: K072526, K070456 Manufacturer: Micrus Endovascular Corporation The SwiftNINJA® Microcath… | 2007 |
What descends from it? (4)
3 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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K190126 (Bend IT Technologies, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K082613.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161921: SwiftNINJA Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161921
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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