510(k) · Cleared
ClearedASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
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 Apr 3, 2017 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 26 other predicates after a 118-day review. Its family tree reaches back 13 generations to 1989. 11 later devices descend from it.
- Decided
- Apr 3, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 27
Its longest line of descent runs back 13 generations to K890505 (1989). 42 ancestors in all. 11 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations between
- 3 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 2 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 1 generation backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- This deviceK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK203533 Vassallo GTFilmecc Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK203529 VASSALLO GT HybridFilmecc Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK243733 SION blue PLUSAsahi Intecc Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241962 CrossloopAsahi Intecc Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241702 CROSSLEAD 0.014inchAsahi Intecc Co., Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 12 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 11 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 10 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 9 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 8 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 7 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 6 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 5 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 4 generations backK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- 3 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 2 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 1 generation backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- This deviceK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
2018high 3 (2023) · low 0 (2019)2026
Most influential descendants
Showing 5 of 11 · See all- K203533Vassallo GTFilmecc Co., Ltd. · 2021 · cites it directly3descendants
- K203529VASSALLO GT HybridFilmecc Co., Ltd. · 2021 · cites it directly1descendant
- K243733SION blue PLUSAsahi Intecc Co., Ltd. · 2025 · cites it directly0descendants
- K241962CrossloopAsahi Intecc Co., Ltd. · 2025 · cites it directly0descendants
- K241702CROSSLEAD 0.014inchAsahi 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 |
|---|---|---|---|---|---|
| −13 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −12 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −11 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −10 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −9 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −8 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −7 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −6 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −5 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| −4 | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| −3 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| −2 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| −1 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
| 0 (this device) | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
| +1 | K203533 | Vassallo GT | Filmecc Co., Ltd. | 2021 | — |
| +1 | K203529 | VASSALLO GT Hybrid | Filmecc Co., Ltd. | 2021 | — |
| +1 | K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025 | — |
| +1 | K241962 | Crossloop | Asahi Intecc Co., Ltd. | 2025 | — |
| +1 | K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (27)
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 |
|---|---|---|---|
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 4…CFR §870.1330 CLASSIFICATION NAME: Catheter Guide Wire PRODUCT CODE DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431,… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 4….1330 CLASSIFICATION NAME: Catheter Guide Wire PRODUCT CODE DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431,… | 2003 |
| * | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Summary page 4…SSIFICATION NAME: Catheter Guide Wire PRODUCT CODE DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705… | 2003 |
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 4…ON NAME: Catheter Guide Wire PRODUCT CODE DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904… | 2004 |
| * | K043422 | Asahi Ptca Guide Wire, J Shape SeriesSummary page 4…DUCT CODE DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469,… | 2005 |
| * | K052022 | Asahi Ptca Guide Wire FielderSummary page 4…DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469,… | 2005 |
| * | K052339 | Asahi Ptca Guide WireSummary page 4…DQX – Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469,… | 2005 |
| * | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JSummary page 4…– Wire, Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469,… | 2006 |
| * | K063819 | Asahi Ptca Guide Wire, Fielder FCSummary page 4…Guide, Catheter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865… | 2007 |
| * | K072431 | Asahi Ptca Guide Wire, X-TremeSummary page 4…theter PREDICATE DEVICES: • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106… | 2007 |
| * | K072705 | Asahi Ptca Guide Wire, Fielder FC J, Models: AGP140001J, AGP140301JSummary page 4…AHI PTCA Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI P… | 2007 |
| * | K083904 | Asahi Suoh Ptca Guide WireSummary page 4…Guide Wires (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral… | 2009 |
| * | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SSummary page 4…es (K022762, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wi… | 2010 |
| * | K101986 | Asahi Ultimatebros 3 Ptca Guide WireSummary page 4…62, K031277, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061… | 2011 |
| * | K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Summary page 4…77, K032615, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071… | 2013 |
| * | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJSummary page 4…15, K041531, K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083… | 2013 |
| * | K133865 | Asahi Gaia First, Second, ThirdSummary page 4…K043422, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103… | 2014 |
| * | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-RSummary page 4…22, K052022, K052339, K062186. K063819, K072431, K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110… | 2016 |
| * | K061984 | TreasureSummary page 4…K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire… | 2006 |
| * | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Summary page 4…K072705, K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extensio… | 2007 |
| * | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Summary page 4…K083904, K100578, K101986, K122468, K122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K08314… | 2008 |
| * | K103057 | Asahi Astato XS 20 Peripheral Guide WireSummary page 4…122469, K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED U… | 2010 |
| * | K110553 | Asahi Treasure Floppy Peripheral Guide WireSummary page 4…K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED USE/INDICA… | 2011 |
| * | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Summary page 4…K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED USE/INDICATIONS FOR… | 2015 |
| * | K153443 | ASAHI Astato XS 40Summary page 4…K133865, K153106) • ASAHI Peripheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED USE/INDICATIONS FOR USE The… | 2016 |
| * | K083145 | Asahi Guide Wire Extension, Model AG149000Summary page 4…ipheral Guide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED USE/INDICATIONS FOR USE The intended use of these wires are unchanged: ASAHI PTCA Guide Wire… | 2009 |
| * | K101985 | Asahi Guide Wire Extension 165CMSummary page 4…uide Wires (K061984, K071721, K083146, K103057, K110553, K150445, K153443) • ASAHI Guide Wire Extension (K083145, K101985) INTENDED USE/INDICATIONS FOR USE The intended use of these wires are unchanged: ASAHI PTCA Guide Wires:… | 2011 |
What descends from it? (11)
See all 117 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 28 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K203533 (Filmecc Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 22 other devices also cite its predicate K022762.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2007high 21 (2010) · low 6 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
2007high 212 (2022) · low 43 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
2007high 49 (2009) · low 0 (2014)2026
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
2007high 2,210 (2024) · low 687 (2009)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 PTCA Guide Wires: ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. ASAHI Peripheral Guide Wires: ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during…
Read the full statement (108 words)
ASAHI PTCA Guide Wires:
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI Peripheral Guide Wires:
ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
ASAHI Guide Wire Extension:
The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163426
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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