510(k) · Cleared
ClearedAsahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S
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 Sep 22, 2010 as substantially equivalent to K083904 (Asahi Intecc Co., Ltd., 2009) and 2 other predicates after a 205-day review. Its family tree reaches back 9 generations to 1989. 36 later devices descend from it.
- Decided
- Sep 22, 2010
- Review
- 205 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K890505 (1989). 17 ancestors in all. 36 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations between
- 3 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 2 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 1 generation backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- This deviceK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- Descendant · cites it directly · 31 of its ownK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- Descendant · cites it directly · 29 of its ownK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- Descendant · 2 generations on · 21 of its ownK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- Descendant · cites it directly · 16 of its ownK122468 Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire…Asahi Intecc Co., Ltd. · 2013
- Descendant · cites it directly · 11 of its ownK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
Show all 9 generations
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 7 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 6 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 5 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 4 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 3 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 2 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 1 generation backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- This deviceK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd. · 2013 · cites it directly31descendants
- K133865Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014 · cites it directly29descendants
- K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016 · 2 generations on21descendants
- K122468Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Asahi Intecc Co., Ltd. · 2013 · cites it directly16descendants
- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. · 2017 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −8 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −7 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −6 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −5 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −4 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −3 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −1 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| 0 (this device) | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| +1 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| +1 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| +2 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
| +1 | K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion… | Asahi Intecc Co., Ltd. | 2013 | — |
| +1 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K083904 | Asahi Suoh Ptca Guide WireSummary page 1…uide, Catheter DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi - SUOH PTCA Guide Wire - 510(k) K<083904 Asahi -Asahi PTCA Guide Wire - 51 0(k) K070945 Asahi - JoWire Neo's PTCA Guide Wire -… | 2009 |
| * | K070945 | Asahi Ptca Guide WireSummary page 1…ASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi - SUOH PTCA Guide Wire - 510(k) K<083904 Asahi -Asahi PTCA Guide Wire - 51 0(k) K070945 Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOT… | 2008 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…TCA Guide Wire - 510(k) K<083904 Asahi -Asahi PTCA Guide Wire - 51 0(k) K070945 Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:2 The ASAHI SION PTCA Guide Wire is a steerable guide wire with a… | 2002 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | 2013 | 31 |
| K133865 | Asahi Gaia First, Second, Third | 2014 | 29 |
| K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM… | 2013 | 16 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K191464 | Asahi PTCA Guide Wire Asahi SION Series | 2019 | 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 21 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K122469 (Asahi Intecc Co., Ltd., 2013) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K083904.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The ASAHI SIGN PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI SIGN PTCA Guide Wire is not to be used in the cerebral blood vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100578: Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100578
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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