510(k) · Cleared
Recalled · Class II · 2022Trevo Trak 21 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 22, 2019 as substantially equivalent to K113260 (Concentric Medical, Inc., 2012) after a 108-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003086 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
- 3 generations backK091961 Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc. · 2009
- 2 generations backK111619 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2011
- 1 generation backK113260 Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012 · Recalled
- This deviceK192122 Trevo Trak 21 MicrocatheterStryker · 2019
- Descendant · cites it directly · 2 of its ownK211594 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK261889 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026
- Descendant · 2 generations on · 0 of its ownK250960 DUO MicrocatheterRev Neuro, LLC · 2025
- Descendant · cites it directly · 0 of its ownK202926 Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K211594Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · cites it directly2descendants
- K261889Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026 · 2 generations on0descendants
- K250960DUO MicrocatheterRev Neuro, LLC · 2025 · 2 generations on0descendants
- K202926Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003086 | Concentric Micro Catheter, Models 90001 to 90008 | Concentric Medical, Inc. | 2001 | — |
| −3 | K091961 | Modified Concentric Microcatheter, Model 90047 | Concentric Medical, Inc. | 2009 | — |
| −2 | K111619 | Modified Concentric Microcatheter | Concentric Medical, Inc. | 2011 | — |
| −1 | K113260 | Modified Concentirc Microcatheter | Concentric Medical, Inc. | 2012 | 5 |
| 0 (this device) | K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019 | — |
| +1 | K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2021 | 3 |
| +2 | K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026 | — |
| +2 | K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025 | — |
| +1 | K202926 | Micro Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K113260 | Modified Concentirc MicrocatheterSummary page 4…510(k) Manufacturer Number Trevo® Pro 18 Stryker K113260 Microcatheter Neurovascular Device Description The Trevo Trak 21 Microcatheter is a single-lumen,… | 2012 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2022 | Class II | Z-1386-2022 | Labeling mix-ups | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K211594 (Stryker Neurovascular, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K113260.
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 Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192122: Trevo Trak 21 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192122
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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