510(k) · Cleared
ClearedBendit2.7 Steerable Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bend IT Technologies, Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 22, 2019 as substantially equivalent to K161921 (Merit Medical Systems, Inc., 2016) after a 206-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 22, 2019
- Review
- 206 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960806 (1996). 13 ancestors in all, the oldest K925813 (1994). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK211110 Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019 | — |
| +1 | K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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…KRA Review Panel: Cardiovascular Class: II E. Predicate Device: Primary: SwiftNINJA, K161921 Reference: Direxion Torqueable MicrocathetHU. F. Summary Device Description:… | 2016 |
| † | K132947 | Direxion and Direxion HI-Flo Torqueable Microcatheters | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200582 | Bendit2.7 Steerable Microcatheter | 2020 | 1 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K200582 (Bend IT Technologies, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K161921.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.
The Bendit2.7 is not intended to be used in intracranial or coronary vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190126: Bendit2.7 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/K190126
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