510(k) · Cleared
ClearedModified Concentric Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 6, 2011 as substantially equivalent to K091961 (Concentric Medical, Inc., 2009) after a 26-day review. Its family tree reaches back 2 generations to 2001. 7 later devices descend from it.
- Decided
- Jul 6, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003086 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
- 1 generation backK091961 Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc. · 2009
- This deviceK111619 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK113260 Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK192122 Trevo Trak 21 MicrocatheterStryker · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK211594 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · Recalled
- Descendant · 4 generations on · 0 of its ownK261889 Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026
- Descendant · 4 generations on · 0 of its ownK250960 DUO MicrocatheterRev Neuro, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113260Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012 · cites it directly6descendants
- K192122Trevo Trak 21 MicrocatheterStryker · 2019 · 2 generations on4descendants
- K211594Trevo Trak 21 MicrocatheterStryker Neurovascular · 2021 · 3 generations on2descendants
- K261889Trevo Trak 21 MicrocatheterStryker Neurovascular · 2026 · 4 generations on0descendants
- K250960DUO MicrocatheterRev Neuro, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003086 | Concentric Micro Catheter, Models 90001 to 90008 | Concentric Medical, Inc. | 2001 | — |
| −1 | K091961 | Modified Concentric Microcatheter, Model 90047 | Concentric Medical, Inc. | 2009 | — |
| 0 (this device) | K111619 | Modified Concentric Microcatheter | Concentric Medical, Inc. | 2011 | — |
| +1 | K113260 | Modified Concentirc Microcatheter | Concentric Medical, Inc. | 2012 | 5 |
| +2 | K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019 | 1 |
| +3 | K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2021 | 3 |
| +4 | K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026 | — |
| +4 | K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K091961 | Modified Concentric Microcatheter, Model 90047Summary page 1…during diagnostic and/or therapeutic procedures. Technological Characteristics The Modified Concentric Microcatheter has the same technological characteristics as the K091961 predicate device. The device design, materials used, function, physical properties and composition have not been changed. Testi… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113260 | Modified Concentirc Microcatheter | 2012 | 6 |
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 10 years and passes through 1 company; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113260 (Concentric Medical, Inc., 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents 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/K111619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111619: Modified Concentric Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111619
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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