510(k) · Cleared
ClearedAsahi Suoh 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 29, 2009 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 2 other predicates after a 31-day review. Its family tree reaches back 7 generations to 1989. 37 later devices descend from it.
- Decided
- Jan 29, 2009
- Review
- 31 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K890505 (1989). 10 ancestors in all. 37 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 3 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 2 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 1 generation backK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- This deviceK083904 Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd. · 2009
- 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 · 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
- Descendant · 2 generations on · 16 of its ownK122468 Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire…Asahi Intecc Co., Ltd. · 2013
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · 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
- 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
- K122468Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Asahi Intecc Co., Ltd. · 2013 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −3 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −2 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −1 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| 0 (this device) | K083904 | Asahi Suoh Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2009 | — |
| +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 | — |
| +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 | — |
| +2 | K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion… | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…ire, Guide, Catheter DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: JoWire Neo's PTCA Guide Wire - 510(k) K022762 JoWire Asahi PTCA Guide Wire - 510(k) K031277 Asahi PTCA Guide Wire - 510(k) K052339 DESC… | 2002 |
| * | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models…Summary page 1…70.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: JoWire Neo's PTCA Guide Wire - 510(k) K022762 JoWire Asahi PTCA Guide Wire - 510(k) K031277 Asahi PTCA Guide Wire - 510(k) K052339 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asa… | 2003 |
| * | K052339 | Asahi Ptca Guide WireSummary page 1…TE DEVICE: JoWire Neo's PTCA Guide Wire - 510(k) K022762 JoWire Asahi PTCA Guide Wire - 510(k) K031277 Asahi PTCA Guide Wire - 510(k) K052339 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi SUOH PTCA Guide Wire is A steerable guide wire with a… | 2005 |
What descends from it? (37)
See all 373 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 20 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 10 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. 2009, 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?
The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083904: Asahi Suoh Ptca Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083904
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