510(k) · Cleared
ClearedAsahi Chikai 10 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 Dec 1, 2011 as substantially equivalent to K110584 (Asahi Intecc Co., Ltd., 2011) and 3 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1989. 6 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K890505 (1989). 10 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 4 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 3 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 2 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 1 generation backK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- This deviceK112979 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 · 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
- Descendant · 2 generations on · 0 of its ownK183070 ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK171613 ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2015 · cites it directly4descendants
- K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd. · 2025 · 2 generations on0descendants
- K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. · 2024 · cites it directly0descendants
- K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd. · 2019 · 2 generations on0descendants
- K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −4 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −3 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −2 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −1 | K110584 | Asahi Chikai Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025 | — |
| +1 | K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024 | — |
| +2 | K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | 2019 | — |
| +2 | K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | Asahi Intecc Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K110584 | Asahi Chikai Neurovascular Guide WireSummary page 1…2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE MOF - Catheter Guide Wire PREDICATE DEVICE: 1. Asahi - ASAHI CHIKAL Neurovascular Guide Wire - 51 0(k) K1 10584 2. Micro Therapeutics, Inc. / 2V3 - SilverSpeed Hydrophilic Guidewire - 510(k) K99… | 2011 |
| * | K993257 | .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016…Summary page 1…Neurovascular Guide Wire - 51 0(k) K1 10584 2. Micro Therapeutics, Inc. / 2V3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 3. Asahi - JoWire Neos PTCA Guide Wire - 510(k) K022762 4. BSC/SciMed Life Systems, I… | 1999 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…rapeutics, Inc. / 2V3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 3. Asahi - JoWire Neos PTCA Guide Wire - 510(k) K022762 4. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -51 0(k) K971 25… | 2002 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…- JoWire Neos PTCA Guide Wire - 510(k) K022762 4. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -51 0(k) K971 254 Additional referenced 510(k) cleared device: 5. Asahi - ASAHI SION PTCA Guide Wire -… | 1997 |
| † | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | 2010 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K141751 (Asahi Intecc Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K110584.
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/K112979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112979: Asahi Chikai 10 Neurovascular Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112979
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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