510(k) · Cleared
ClearedAsahi Chikai V Peripheral Vascular Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Feb 6, 2012 as substantially equivalent to K993257 (Micro Therapeutics, Inc., 1999) and 3 other predicates after a 49-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Feb 6, 2012
- Review
- 49 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K890505 (1989). 10 ancestors in all. 1 later device descends from it, 1 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 deviceK113716 Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK161584 ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd. · 2016 · cites it directly0descendants
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) | K113716 | Asahi Chikai V Peripheral Vascular Guide Wire | Asahi Intecc Co., Ltd. | 2012 | — |
| +1 | K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 | Asahi Intecc Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 2016 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K993257 | .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016…Summary page 1…ODUCT CODE DQX - Catheter Guide Wire PREDICATE DEVICE: 1. Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 2. Asahi - ASAHI CHIKAI Neurovascular Guide Wire -510(k) K1 10584 3. Asahi - JoWire N… | 1999 |
| * | K110584 | Asahi Chikai Neurovascular Guide WireSummary page 1…ics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire - 510(k) K993257 2. Asahi - ASAHI CHIKAI Neurovascular Guide Wire -510(k) K1 10584 3. Asahi - JoWire Neos PTCA Guide Wire - 510(k) K022762 4. 830/SciMed Life Systems, I… | 2011 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…K993257 2. Asahi - ASAHI CHIKAI Neurovascular Guide Wire -510(k) K1 10584 3. Asahi - JoWire Neos PTCA Guide Wire - 510(k) K022762 4. 830/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -510(k) K971 254… | 2002 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…sahi - JoWire Neos PTCA Guide Wire - 510(k) K022762 4. 830/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -510(k) K971 254 Additional referenced 51 0(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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 | 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 23 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, K161584 (Asahi Intecc Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K993257.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113716: Asahi Chikai V Peripheral Vascular 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/K113716
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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