510(k) · Cleared
ClearedAsahi Ptca 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 Jan 9, 2008 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 8 other predicates after a 280-day review. Its family tree reaches back 8 generations to 1989. 48 later devices descend from it.
- Decided
- Jan 9, 2008
- Review
- 280 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K890505 (1989). 15 ancestors in all. 48 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 4 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 3 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 2 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 1 generation backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- This deviceK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- Descendant · cites it directly · 36 of its ownK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- Descendant · 2 generations on · 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 · 30 of its ownK101986 Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd. · 2011
- Descendant · 2 generations on · 29 of its ownK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- Descendant · 3 generations on · 21 of its ownK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K100578Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010 · cites it directly36descendants
- K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd. · 2013 · 2 generations on31descendants
- K101986Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd. · 2011 · cites it directly30descendants
- K133865Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014 · 2 generations on29descendants
- K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −4 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −3 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −2 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| 0 (this device) | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| +1 | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| +2 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| +1 | K101986 | Asahi Ultimatebros 3 Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| +2 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| +3 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (9)
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 1…de Wire COMMON NAME: Guide Wire YCLASSIFECATION .NAME: Catheter Guide Wire DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: k- PRODUCT CODE DQX : t PREDICATE DEVICE: K022762 JoWire Neo’s PTCA Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 1…IFECATION .NAME: Catheter Guide Wire DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: k- PRODUCT CODE DQX : t PREDICATE DEVICE: K022762 JoWire Neo’s PTCA Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wir… | 2003 |
| * | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Summary page 1…VICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: k- PRODUCT CODE DQX : t PREDICATE DEVICE: K022762 JoWire Neo’s PTCA Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA… | 2003 |
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 1…330 CLASSIFICATION: k- PRODUCT CODE DQX : t PREDICATE DEVICE: K022762 JoWire Neo’s PTCA Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339… | 2004 |
| * | K043422 | Asahi Ptca Guide Wire, J Shape SeriesSummary page 1…: t PREDICATE DEVICE: K022762 JoWire Neo’s PTCA Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339 Asahi PTCA Guide Wire “' K062186 Asahi P… | 2005 |
| * | K052022 | Asahi Ptca Guide Wire FielderSummary page 1…Guide Wire ‘ K031277 JoWire Asahi PTCA Guide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339 Asahi PTCA Guide Wire “' K062186 Asahi PTCA Guide Wire, Fielder J K063819 Asahi PTCA Gui… | 2005 |
| * | K052339 | Asahi Ptca Guide WireSummary page 1…ide Wire i K032615 Asahi PTCA Guide Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339 Asahi PTCA Guide Wire “' K062186 Asahi PTCA Guide Wire, Fielder J K063819 Asahi PTCA Guide Wire, Fielder FC CONFIDENTIAL Asahi I… | 2005 |
| * | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JSummary page 1…de Wire K041531 Asahi PTCA Guide Wire Confianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339 Asahi PTCA Guide Wire “' K062186 Asahi PTCA Guide Wire, Fielder J K063819 Asahi PTCA Guide Wire, Fielder FC CONFIDENTIAL Asahi Intecc March 20, 2007 000189 ===… | 2006 |
| * | K063819 | Asahi Ptca Guide Wire, Fielder FCSummary page 1…fianza K043422 Asahi PTCA Guide Wire, J Shape Series “ K052022 Asahi PTCA Guide Wire, Fielder g K052339 Asahi PTCA Guide Wire “' K062186 Asahi PTCA Guide Wire, Fielder J K063819 Asahi PTCA Guide Wire, Fielder FC CONFIDENTIAL Asahi Intecc March 20, 2007 000189… | 2007 |
What descends from it? (48)
See all 484 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 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K100578 (Asahi Intecc Co., Ltd., 2010) has gone furthest, with 36 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. 2008, 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 PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070945: Asahi Ptca 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/K070945
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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