510(k) · Cleared
Recalled · Class II · 2024Modified 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 Oct 11, 2013 as substantially equivalent to K113260 (Concentric Medical, Inc., 2012) after a 144-day review. Its family tree reaches back 4 generations to 2001. It has been recalled 2 times.
- Decided
- Oct 11, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003086 (2001). No later device cites it as a predicate yet.
- 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 deviceK131437 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2013
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) | K131437 | Modified Concentric Microcatheter | Concentric Medical, Inc. | 2013 | — |
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 1…Rowe Manager, Regulatory Affairs Date Prepared: September 6, 2013 Predicate Device: Concentric Microcatheter (K1 13260) Device Description The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1904-2024 | 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-1084-2024 | 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 12 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2013, 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/K131437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131437: 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/K131437
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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