510(k) · Cleared
ClearedFUBUKI XF-R Neurovascular Long Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Jun 20, 2025 as substantially equivalent to K213589 (Asahi Intecc Co., Ltd., 2022) after a 30-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 20, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003880 (2001). 8 ancestors in all, the oldest K962362 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 4 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 3 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 2 generations backK141981 Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd. · 2015
- 1 generation backK213589 FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2022
- This deviceK251560 FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −4 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −3 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −2 | K141981 | Asahi Fubuki 043 / Asahi Fubuki | Asahi Intecc Co., Ltd. | 2015 | — |
| −1 | K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022 | — |
| 0 (this device) | K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K213589 | FUBUKI XF Neurovascular Long SheathSummary page 5…Percutaneous Catheter Product Code: QJP – Catheter, Percutaneous, Neurovasculature Predicate Device: FUBUKI XF Neurovascular Long Sheath (K213589) Intended Use/Indications For Use The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interv… | 2022 |
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 24 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.
The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251560: FUBUKI XF-R Neurovascular Long Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251560
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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