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 Nov 30, 2005 as substantially equivalent to K041531 (Asahi Intecc Co., Ltd., 2004) and 2 other predicates after a 96-day review. Its family tree reaches back 6 generations to 1989. 3 of the 70 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it.
- Decided
- Nov 30, 2005
- Review
- 96 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K890505 (1989). 9 ancestors in all. 60 later devices descend from it, 9 citing it directly. 3 of the 70 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 1 generation backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- This deviceK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 48 of its ownK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- Descendant · cites it directly · 37 of its ownK083904 Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd. · 2009
- Descendant · 2 generations on · 36 of its ownK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- Descendant · 3 generations on · 31 of its ownK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- Descendant · 2 generations on · 30 of its ownK101986 Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd. · 2011
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008 · cites it directly48descendants
- K083904Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd. · 2009 · cites it directly37descendants
- K100578Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010 · 2 generations on36descendants
- K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd. · 2013 · 3 generations on31descendants
- K101986Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd. · 2011 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −1 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| 0 (this device) | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| +1 | K083904 | Asahi Suoh Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2009 | — |
| +2 | 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 | K101986 | Asahi Ultimatebros 3 Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 1 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 1 |
| 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.
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? (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 |
|---|---|---|---|
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 1…Guide Wire DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE DOX PREDICATE DEVICE: Asahi PTCA Guide Wire Confianza Pro K041531 JOWIRE Asahi PTCA Guide Wire K(031277 JOWIRE Neo's PTCA Gukie Wire K022762… | 2004 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 1…0 CLASSIFICATION: PRODUCT CODE DOX PREDICATE DEVICE: Asahi PTCA Guide Wire Confianza Pro K041531 JOWIRE Asahi PTCA Guide Wire K(031277 JOWIRE Neo's PTCA Gukie Wire K022762 NOTIFICA… | 2003 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…VICE: Asahi PTCA Guide Wire Confianza Pro K041531 JOWIRE Asahi PTCA Guide Wire K(031277 JOWIRE Neo's PTCA Gukie Wire K022762 NOTIFICATION: DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKETr… | 2002 |
What descends from it? (60)
See all 609 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070945 | Asahi Ptca Guide Wire | 2008 | 48 |
| K083904 | Asahi Suoh Ptca Guide Wire | 2009 | 37 |
| K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | 2007 | 27 |
| K103057 | Asahi Astato XS 20 Peripheral Guide Wire | 2010 | 21 |
| 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 |
| K082304 | Roll-X Guidewire | 2008 | 2 |
| K152497 | PW Guidewires | 2016 | 0 |
| K100710 | Roll-X Guidewire | 2010 | 0 |
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 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K070945 (Asahi Intecc Co., Ltd., 2008) has gone furthest, with 48 descendants of its own.
- 11 other devices also cite its predicate K041531.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K052339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052339: 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/K052339
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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