510(k) · Cleared
ClearedAsahi Chikai Neurovascular Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Aug 22, 2011 as substantially equivalent to K993257 (Micro Therapeutics, Inc., 1999) and 2 other predicates after a 174-day review. Its family tree reaches back 4 generations to 1989. 11 later devices descend from it.
- Decided
- Aug 22, 2011
- Review
- 174 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890505 (1989). 9 ancestors in all. 11 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 3 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 2 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 1 generation backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- This deviceK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK112979 Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK141751 Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular…Asahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK113716 Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK243383 CHIKAI Nexus 014Asahi Intecc Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240871 Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011 · cites it directly6descendants
- K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2015 · cites it directly4descendants
- K113716Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd. · 2012 · cites it directly1descendant
- K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd. · 2025 · 2 generations on0descendants
- K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −3 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −2 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −1 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| 0 (this device) | K110584 | Asahi Chikai Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| +1 | K112979 | Asahi Chikai 10 Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| +1 | K141751 | Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide… | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K113716 | Asahi Chikai V Peripheral Vascular Guide Wire | Asahi Intecc Co., Ltd. | 2012 | — |
| +2 | K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025 | — |
| +1 | K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 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? (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 |
|---|---|---|---|
| * | K993257 | .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016…Summary page 1…CT CODE DQX - Catheter Guide Wire PREDICATE DEVICE: 1. Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 2. Asahi - JoWire Nec's PTCA Guide Wire - 510(k) K(022762 3. BSC/SciMed Life Systems,… | 1999 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…eutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 2. Asahi - JoWire Nec's PTCA Guide Wire - 510(k) K(022762 3. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -51 0(k) K(97125… | 2002 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…oWire Nec's PTCA Guide Wire - 510(k) K(022762 3. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -51 0(k) K(971254 Additional referenced 51 0(k) cleared device: 4. Asahi - ASAHI SION PTCA Guide Wire -… | 1997 |
| † | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | 2010 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112979 | Asahi Chikai 10 Neurovascular Guide Wire | 2011 | 6 |
| K141751 | Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi… | 2015 | 4 |
| K113716 | Asahi Chikai V Peripheral Vascular Guide Wire | 2012 | 1 |
| K240871 | Synxess Neurovascular Guidewire | 2024 | 0 |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | 2019 | 0 |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | 2016 | 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 22 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K112979 (Asahi Intecc Co., Ltd., 2011) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K993257.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110584: Asahi Chikai Neurovascular Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110584
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