510(k) · Cleared
ClearedAsahi Fubuki 043 / Asahi Fubuki
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous
Cleared on Mar 9, 2015 as substantially equivalent to K090335 (Concentric Medical, Inc., 2009) and 2 other predicates after a 231-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 9, 2015
- Review
- 231 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003880 (2001). 6 ancestors in all, the oldest K962362 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 2 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 1 generation backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- This deviceK141981 Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK213589 FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251560 FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −2 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −1 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| 0 (this device) | K141981 | Asahi Fubuki 043 / Asahi Fubuki | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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? (3)
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 |
|---|---|---|---|
| * | K090335 | HD Guide CatheterSummary page 4…Class 2 per 21 CFR §870.1250 CLASSIFICATION: CLASSIFICATION Percutaneous Catheter NAME: PRODUCT CODE DQY PREDICATE K090335, HD Guide Catheter DEVICES: K962362, Envoy Guide Catheter K980453, GUIDER Softip Guiding… | 2009 |
| * | K962362 | Cordis Envoy & Vista Brite Tip Guiding CathetersSummary page 4…IFICATION: CLASSIFICATION Percutaneous Catheter NAME: PRODUCT CODE DQY PREDICATE K090335, HD Guide Catheter DEVICES: K962362, Envoy Guide Catheter K980453, GUIDER Softip Guiding Catheter REFERENCE K083127, Asahi C… | 1996 |
| * | K980453 | Schneider Guider Softip Guiding CathetersSummary page 4…er NAME: PRODUCT CODE DQY PREDICATE K090335, HD Guide Catheter DEVICES: K962362, Envoy Guide Catheter K980453, GUIDER Softip Guiding Catheter REFERENCE K083127, Asahi Corsair Microcatheter DEVICES: K132556,… | 1998 |
| † | K083127 | Asahi Corsair Microcatheter | 2009 |
| † | K132556 | Sheathless Eaucath Coronary Guide Catheter | 2013 |
| † | K061601 | Asahi Precious Guide Catheter | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213589 | FUBUKI XF Neurovascular Long Sheath | 2022 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K213589 (Asahi Intecc Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K090335.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are 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 catheter is also intended to be used for injection of contrast media. Do not use this catheter other than for use in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141981: Asahi Fubuki 043 / Asahi Fubuki.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141981
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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