510(k) · Cleared
ClearedSION blue PLUS
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 Apr 2, 2025 as substantially equivalent to K122468 (Asahi Intecc Co., Ltd., 2013) and 2 other predicates after a 119-day review. Its family tree reaches back 14 generations to 1989.
- Decided
- Apr 2, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K890505 (1989). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 10 generations between
- 3 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 2 generations backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- 1 generation backK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- This deviceK243733 SION blue PLUSAsahi Intecc Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 13 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 12 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 11 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 10 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 9 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 8 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 7 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 6 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 5 generations backK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- 4 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 3 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 2 generations backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- 1 generation backK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- This deviceK243733 SION blue PLUSAsahi Intecc Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −13 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −12 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −11 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −10 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −9 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −8 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −7 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −6 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| −5 | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| −4 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| −3 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| −2 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
| −1 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
| 0 (this device) | K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Summary page 5…Guide, Wire Product Code DQX – Catheter Guide Wire Predicate Device ASAHI PTCA Guide Wire ASAHI SION blue * (K122468, K163426, K191464) Reference Device MINAMO blue; MINAMO viola ** (K240387) *Referred to as SION blue ** Referred… | 2013 |
| * | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionSummary page 5…ire Product Code DQX – Catheter Guide Wire Predicate Device ASAHI PTCA Guide Wire ASAHI SION blue * (K122468, K163426, K191464) Reference Device MINAMO blue; MINAMO viola ** (K240387) *Referred to as SION blue ** Referred to as MI… | 2017 |
| * | K191464 | Asahi PTCA Guide Wire Asahi SION SeriesSummary page 5…ct Code DQX – Catheter Guide Wire Predicate Device ASAHI PTCA Guide Wire ASAHI SION blue * (K122468, K163426, K191464) Reference Device MINAMO blue; MINAMO viola ** (K240387) *Referred to as SION blue ** Referred to as MINAMO blue… | 2019 |
| † | K240387 | MINAMO blue; MINAMO viola | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 44 ancestors have a recall of any class.
- 4 other devices also cite its predicate K122468.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243733 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243733: SION blue PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243733
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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