510(k) · Cleared
ClearedAsahi Ptca Guide Wire Confianza Pro
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 Aug 3, 2004 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1989. 3 of the 88 devices in its family, counting itself, have a Class I recall. 79 later devices descend from it.
- Decided
- Aug 3, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K890505 (1989). 8 ancestors in all. 79 later devices descend from it, 12 citing it directly. 3 of the 88 devices in this family, counting this one, have a Class I recall.
- 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 backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- This deviceK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- Descendant · cites it directly · 60 of its ownK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 50 of its ownK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- Descendant · 2 generations on · 49 of its ownK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- Descendant · cites it directly · 48 of its ownK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- Descendant · 2 generations on · 37 of its ownK083904 Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd. · 2009
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 79 · See all- K052339Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005 · cites it directly60descendants
- K043422Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005 · cites it directly50descendants
- K062186Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006 · 2 generations on49descendants
- K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008 · cites it directly48descendants
- K083904Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd. · 2009 · 2 generations on37descendants
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 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| 0 (this device) | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +1 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | 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 | — |
| +2 | K083904 | Asahi Suoh Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 1 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 1 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 1 |
| 2026 | 2 | 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.
3 devices in this family have a Class I recall. 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? (2)
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…e Asahi PTCA Guide Wire Confianza Pro Classification Name: Catheter Guide Wire, Class II (21 CER 870.1330) Predicate Device: JoWire Neo's PI CA Guide Wire K022762 JoWire Asahi PTICA Guide Wire K031277 Device Description: The Asahi PTCA Guide Wire Confianza Pro i… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 1…Catheter Guide Wire, Class II (21 CER 870.1330) Predicate Device: JoWire Neo's PI CA Guide Wire K022762 JoWire Asahi PTICA Guide Wire K031277 Device Description: The Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum diameter of 0.014" and ava… | 2003 |
What descends from it? (79)
See all 7912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052339 | Asahi Ptca Guide Wire | 2005 | 60 |
| K043422 | Asahi Ptca Guide Wire, J Shape Series | 2005 | 50 |
| K070945 | Asahi Ptca Guide Wire | 2008 | 48 |
| K101986 | Asahi Ultimatebros 3 Ptca Guide Wire | 2011 | 30 |
| K133865 | Asahi Gaia First, Second, Third | 2014 | 29 |
| K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001 | 2008 | 13 |
| K083727 | Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012 | 2009 | 12 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter | 2018 | 7 |
| K070212 | CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support… | 2007 | 1 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K052339 (Asahi Intecc Co., Ltd., 2005) has gone furthest, with 60 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.
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?
To facilitate the placement of balloon dilatation catheters during perculaneous 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 as stated in the FDA summary.
https://510kreport.com/device/K041531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041531: Asahi Ptca Guide Wire Confianza Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041531
Report an extraction error
Are you the manufacturer?
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