510(k) · Cleared
Recalled · Class II · 2024Trevo Trak 21 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Nov 26, 2021 as substantially equivalent to K192122 (Stryker, 2019) after a 186-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 26, 2021
- Review
- 186 days
- Class
- Class II
- Product code
- QJP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003086 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
- 4 generations backK091961 Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc. · 2009
- 3 generations backK111619 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2011
- 2 generations backK113260 Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012 · Recalled
- 1 generation backK192122 Trevo Trak 21 MicrocatheterStryker · 2019 · Recalled
- This deviceK211594 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021
- Descendant · cites it directly · 0 of its ownK261889 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026
- Descendant · cites it directly · 0 of its ownK250960 DUO MicrocatheterRev Neuro, LLC · 2025
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 |
|---|---|---|---|---|---|
| −5 | K003086 | Concentric Micro Catheter, Models 90001 to 90008 | Concentric Medical, Inc. | 2001 | — |
| −4 | K091961 | Modified Concentric Microcatheter, Model 90047 | Concentric Medical, Inc. | 2009 | — |
| −3 | K111619 | Modified Concentric Microcatheter | Concentric Medical, Inc. | 2011 | — |
| −2 | K113260 | Modified Concentirc Microcatheter | Concentric Medical, Inc. | 2012 | 5 |
| −1 | K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019 | 1 |
| 0 (this device) | K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2021 | — |
| +1 | K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026 | — |
| +1 | K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 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 |
|---|---|---|---|
| * | K192122 | Trevo Trak 21 MicrocatheterSummary page 4…510(k) Manufacturer Number Trevo Trak™ 21 Stryker K192122 Microcatheter Neurovascular… | 2019 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Aug 30, 2024 | Class II | Z-0021-2025 | Under Investigation by firm | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. |
| Apr 23, 2024 | Class II | Z-1906-2024 | Process design | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin… |
| Dec 6, 2023 | Class II | Z-1085-2024 | Under Investigation by firm | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K261889 (Stryker Neurovascular, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192122.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
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/K211594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211594: 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/K211594
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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