510(k) · Cleared
ClearedFUBUKI XF 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 Mar 24, 2022 as substantially equivalent to K141981 (Asahi Intecc Co., Ltd., 2015) after a 132-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 24, 2022
- Review
- 132 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003880 (2001). 7 ancestors in all, the oldest K962362 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 3 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 2 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 1 generation backK141981 Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd. · 2015
- This deviceK213589 FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251560 FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −3 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −2 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −1 | K141981 | Asahi Fubuki 043 / Asahi Fubuki | Asahi Intecc Co., Ltd. | 2015 | — |
| 0 (this device) | K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K141981 | Asahi Fubuki 043 / Asahi FubukiSummary page 4…DQY – Catheter, Percutaneous PREDICATE DEVICE(S): ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters (K141981) Intended Use/Indications for Use: This product is intended to be used to guide interventional devices for neurovascular… | 2015 |
| * | — | Asahi Fubuki 043 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | 2025 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K251560 (Asahi Intecc Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
This product 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. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.
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/K213589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213589: FUBUKI XF Neurovascular Long Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213589
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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