510(k) · Cleared
ClearedJowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jomed, Inc. · DQX Wire, Guide, Catheter
Cleared on May 14, 2003 as substantially equivalent to K022762 (Jomed, Inc., 2002) after a 22-day review. Its family tree reaches back 4 generations to 1989. 3 of the 100 devices in its family, counting itself, have a Class I recall. 92 later devices descend from it.
- Decided
- May 14, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890505 (1989). 7 ancestors in all. 92 later devices descend from it, 12 citing it directly. 3 of the 100 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 3 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 2 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 1 generation backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- This deviceK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- Descendant · cites it directly · 79 of its ownK041531 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 · 59 of its ownK052022 Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 52 of its ownK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- Descendant · 2 generations on · 51 of its ownK063819 Asahi Ptca Guide Wire, Fielder FCAsahi Intecc Co., Ltd. · 2007
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 92 · See all- K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004 · cites it directly79descendants
- K052339Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005 · cites it directly60descendants
- K052022Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005 · cites it directly59descendants
- K032615Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003 · cites it directly52descendants
- K063819Asahi Ptca Guide Wire, Fielder FCAsahi Intecc Co., Ltd. · 2007 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −3 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −2 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −1 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| 0 (this device) | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| +1 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +1 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K052022 | Asahi Ptca Guide Wire Fielder | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| +2 | K063819 | Asahi Ptca Guide Wire, Fielder FC | Asahi Intecc Co., Ltd. | 2007 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 1 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 1 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 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? (1)
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…hi PTCA Guide Wire Device Classification Name and Class: Catheter Guide Wire, Class I1 (21 CFR 870.1330) Predicate Devices: JoWire Asahi PTCA Guide Wire (K022762) Device Description: The JoWire Asahi PTCA Chide Wires are steerable guide wires with a maximum diameter of 0.014” and availabl… | 2002 |
What descends from it? (92)
See all 9212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041531 | Asahi Ptca Guide Wire Confianza Pro | 2004 | 79 |
| K052339 | Asahi Ptca Guide Wire | 2005 | 60 |
| K052022 | Asahi Ptca Guide Wire Fielder | 2005 | 59 |
| K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | 2003 | 52 |
| K043422 | Asahi Ptca Guide Wire, J Shape Series | 2005 | 50 |
| K070945 | Asahi Ptca Guide Wire | 2008 | 48 |
| K083904 | Asahi Suoh Ptca Guide Wire | 2009 | 37 |
| K101986 | Asahi Ultimatebros 3 Ptca Guide Wire | 2011 | 30 |
| 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 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K041531 (Asahi Intecc Co., Ltd., 2004) has gone furthest, with 79 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 percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo’s 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/K031277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031277
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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