510(k) · Cleared
ClearedAgile Devices Angler Steerable, Deflectable Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agile Devices, Inc. · KRA Catheter, Continuous Flush
Cleared on Jan 7, 2022 as substantially equivalent to K200582 (Bend IT Technologies, Ltd., 2020) and 1 other predicate after a 268-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jan 7, 2022
- Review
- 268 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K960806 (1996). 15 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations between
- 3 generations backK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- 2 generations backK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- 1 generation backK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- This deviceK211110 Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 9 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 8 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 7 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 6 generations backK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
- 5 generations backK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
- 4 generations backK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
- 3 generations backK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- 2 generations backK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- 1 generation backK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- This deviceK211110 Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −9 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −8 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −7 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −6 | K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00… | Micrus Endovascular Corporation | 2006 | — |
| −5 | K070456 | Micrus Courier Enzo Microcatheter 0.017 | Micrus Endovascular Corporation | 2007 | — |
| −4 | K072526 | Micrus Courier Enzo Microcatheter 0.0190 | Micrus Endovascular Corporation | 2007 | — |
| −3 | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| −2 | K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019 | — |
| −1 | K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020 | — |
| 0 (this device) | K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K200582 | Bendit2.7 Steerable MicrocatheterSummary page 4…Review Panel: Cardiovascular Class: Class II E. Predicate Device: Primary: Bend It Technologies, Bendit2.7™ Steerable Microcatheter, (K200582) Secondary: Merit Medical, SwiftNINJA (K161921) F. Summary Device Description: The Agile Devices Angler™ Steera… | 2020 |
| * | K161921 | SwiftNINJA MicrocatheterSummary page 4…II E. Predicate Device: Primary: Bend It Technologies, Bendit2.7™ Steerable Microcatheter, (K200582) Secondary: Merit Medical, SwiftNINJA (K161921) F. Summary Device Description: The Agile Devices Angler™ Steerable, Deflectable Microcatheter is a variable stiffness, sing… | 2016 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 15 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. 2022, 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 Agile Devices Angler™ Steerable, Deflectable 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 infusion of diagnostic agents and delivery of embolic or therapeutic devices. Use only contrast media and
therapeutic devices that have been cleared or approved for use in the intended target area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211110: Agile Devices Angler Steerable, Deflectable Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211110
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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