510(k) · Cleared
ClearedWedge XL Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on May 16, 2024 as substantially equivalent to K172014 (MicroVention, Inc., 2018) after a 268-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- May 16, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960806 (1996). 8 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 4 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 3 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 2 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 1 generation backK172014 Wedge MicrocatheterMicroVention, Inc. · 2018
- This deviceK232542 Wedge XL Delivery CatheterMicroVention, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −5 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −4 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −3 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −2 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −1 | K172014 | Wedge Microcatheter | MicroVention, Inc. | 2018 | — |
| 0 (this device) | K232542 | Wedge XL Delivery Catheter | MicroVention, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K172014 | Wedge MicrocatheterSummary page 4…Wedge XL Delivery Catheter Common Name Percutaneous Catheter Classification Class II, QJP Predicate Device Wedge Microcatheter (K172014) Reference Device Delivery Catheter of the Route 92 Medical 088 Access System (K200121)… | 2018 |
| † | K200121 | Route 92 Medical 088 Access System, 110 cm | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K172014.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232542: Wedge XL Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232542
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