510(k) · Cleared
Clearedp17 XR Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallaby Medical · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Aug 18, 2026 as substantially equivalent to K101542 (MicroVention, Inc., 2010) after a 243-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Aug 18, 2026
- Review
- 243 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960806 (1996). 7 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 4 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 3 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 2 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 1 generation backK101542 Headway 17 Advanced MicrocatheterMicroVention, Inc. · 2010 · Recalled
- This deviceK254071 p17 XR MicrocatheterWallaby Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −4 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −3 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −2 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −1 | K101542 | Headway 17 Advanced Microcatheter | MicroVention, Inc. | 2010 | 1 |
| 0 (this device) | K254071 | p17 XR Microcatheter | Wallaby Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K101542 | Headway 17 Advanced MicrocatheterSummary page 5…PREDICATE DEVICE Name of Predicate Device: Headway 17 Advanced Microcatheter Name of Predicate Device Manufacturer: MicroVention, Inc. 510(k) number of Predicate Device: K101542 IV. DEVICE DESCRIPTION Device Description: The p17 XR Microcatheter is a 0.017” inner diameter (ID) single lumen microcatheter… | 2010 |
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 30 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K101542.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 p17 XR Microcatheter is indicated for use with compatible accessories in the delivery of interventional and therapeutic devices and infusion of diagnostic agents, such as contrast media, into the peripheral and neuro vasculature. It is not intended for use in coronary vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254071: p17 XR Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254071
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026