510(k) · Cleared
ClearedAsahi Astato XS 20 Peripheral 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 19, 2010 as substantially equivalent to K071721 (Asahi Intecc Co., Ltd., 2007) and 4 other predicates after a 35-day review. Its family tree reaches back 9 generations to 1989. 21 later devices descend from it.
- Decided
- Nov 19, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K890505 (1989). 26 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations between
- 3 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 2 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 1 generation backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- This deviceK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- Descendant · cites it directly · 16 of its ownK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 14 of its ownK153443 ASAHI Astato XS 40Asahi Intecc Co., Ltd. · 2016
- Descendant · cites it directly · 12 of its ownK110553 Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc. · 2011
- Descendant · cites it directly · 11 of its ownK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK203533 Vassallo GTFilmecc Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 7 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 6 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 5 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 4 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 3 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 2 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 1 generation backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- This deviceK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd. · 2015 · cites it directly16descendants
- K153443ASAHI Astato XS 40Asahi Intecc Co., Ltd. · 2016 · cites it directly14descendants
- K110553Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc. · 2011 · cites it directly12descendants
- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. · 2017 · cites it directly11descendants
- K203533Vassallo GTFilmecc Co., Ltd. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −8 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −7 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −6 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −5 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −4 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −3 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
| +1 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K153443 | ASAHI Astato XS 40 | Asahi Intecc Co., Ltd. | 2016 | — |
| +1 | K110553 | Asahi Treasure Floppy Peripheral Guide Wire | Asahi Intecc USA, Inc. | 2011 | — |
| +1 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
| +2 | K203533 | Vassallo GT | Filmecc Co., Ltd. | 2021 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Summary page 1…EVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE DOX PREDICATE DEVICE: Asahi - Astato 30 Peripheral Guide Wire - 51 0(k) K071 721 Asahi - Treasure Guide Wire - 51 0(k) K(061984 Asahi - JoWire Neo's PTCA Guide Wi… | 2007 |
| * | K061984 | TreasureSummary page 1…CT CODE DOX PREDICATE DEVICE: Asahi - Astato 30 Peripheral Guide Wire - 51 0(k) K071 721 Asahi - Treasure Guide Wire - 51 0(k) K(061984 Asahi - JoWire Neo's PTCA Guide Wire - 5l0(k) K022762 Asahi - Asahi PTCA Guide Wi… | 2006 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…uide Wire - 51 0(k) K071 721 Asahi - Treasure Guide Wire - 51 0(k) K(061984 Asahi - JoWire Neo's PTCA Guide Wire - 5l0(k) K022762 Asahi - Asahi PTCA Guide Wire (Miracle bros l2l~onfianza Pro 12) - 5 10(… | 2002 |
| * | K052339 | Asahi Ptca Guide WireSummary page 1…eo's PTCA Guide Wire - 5l0(k) K022762 Asahi - Asahi PTCA Guide Wire (Miracle bros l2l~onfianza Pro 12) - 5 10(k) K052339 Asahi - Asahi PTCA Guide Wire (FTFE coating type II) -510(k) K070945… | 2005 |
| * | K070945 | Asahi Ptca Guide WireSummary page 1…- 5 10(k) K052339 Asahi - Asahi PTCA Guide Wire (FTFE coating type II) -510(k) K070945 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI Astato XS 20 Peripheral Guide Wire is a steerable guide… | 2008 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | 2015 | 16 |
| K153443 | ASAHI Astato XS 40 | 2016 | 14 |
| K110553 | Asahi Treasure Floppy Peripheral Guide Wire | 2011 | 12 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K213834 | Cardio Flow Peripheral Guide Wire | 2022 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K150445 (Asahi Intecc Co., Ltd., 2015) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K071721.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Astato XS 20 Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures.
This device is intended for peripheral vascular use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103057: Asahi Astato XS 20 Peripheral 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/K103057
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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