510(k) · Cleared
ClearedAsahi Ptca Guide Wire Fielder
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 25, 2005 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1989. 59 later devices descend from it.
- Decided
- Aug 25, 2005
- Review
- 30 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. 59 later devices descend from it, 8 citing it directly.
- 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 deviceK052022 Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 51 of its ownK063819 Asahi Ptca Guide Wire, Fielder FCAsahi Intecc Co., Ltd. · 2007
- Descendant · cites it directly · 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 · 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
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K063819Asahi Ptca Guide Wire, Fielder FCAsahi Intecc Co., Ltd. · 2007 · cites it directly51descendants
- K062186Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006 · cites it directly49descendants
- K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008 · cites it directly48descendants
- 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
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) | K052022 | Asahi Ptca Guide Wire Fielder | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K063819 | Asahi Ptca Guide Wire, Fielder FC | Asahi Intecc Co., Ltd. | 2007 | — |
| +1 | 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 | 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 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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? (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…sahi Wire Asahi PTCA Guide Wire Fielder Classification Name: Catheter Guide Wire, Class II (21 CFR 870.1330) Predicate Device: JoWire Neo's PTCA Guide Wire: K022762 Jo Wire Asahi PTCA Guide Wire: K03 1277 Device Description: The Asahi PTCA Guide Wire Fielder is ste… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 1…Catheter Guide Wire, Class II (21 CFR 870.1330) Predicate Device: JoWire Neo's PTCA Guide Wire: K022762 Jo Wire Asahi PTCA Guide Wire: K03 1277 Device Description: The Asahi PTCA Guide Wire Fielder is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches)… | 2003 |
What descends from it? (59)
See all 598 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063819 | Asahi Ptca Guide Wire, Fielder FC | 2007 | 51 |
| K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | 2006 | 49 |
| K070945 | Asahi Ptca Guide Wire | 2008 | 48 |
| K072705 | Asahi Ptca Guide Wire, Fielder FC J, Models: AGP140001J, AGP140301J | 2007 | 22 |
| K072431 | Asahi Ptca Guide Wire, X-Treme | 2007 | 22 |
| K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | 2008 | 17 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K141751 | Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi… | 2015 | 4 |
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 16 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, K063819 (Asahi Intecc Co., Ltd., 2007) has gone furthest, with 51 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 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/K052022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052022: Asahi Ptca Guide Wire Fielder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052022
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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