510(k) · Cleared
ClearedAsahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371
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 Jul 13, 2007 as substantially equivalent to K061984 (Asahi Intecc Co., Ltd., 2006) and 4 other predicates after an 18-day review. Its family tree reaches back 7 generations to 1989. 3 of the 47 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K890505 (1989). 19 ancestors in all. 27 later devices descend from it, 7 citing it directly. 3 of the 47 devices in this family, counting this one, have a Class I recall.
- 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 deviceK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- Descendant · cites it directly · 21 of its ownK103057 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 · 2 generations on · 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010 · cites it directly21descendants
- 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 · 2 generations on12descendants
- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. · 2017 · cites it directly11descendants
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) | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| +1 | 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 | — |
| +2 | 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 | — |
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 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2021 | 3 | 1 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 1 |
| 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.
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? (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 |
|---|---|---|---|
| * | K061984 | TreasureSummary page 1…Catheter Guide Wire DEVICE Class 2 per 21 CIFR §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi Treasure Guide Wire - K061 984 Guidant Hi-Torque Floppy Guide Wire - K974773 Guidant Hi-Torque Cross-IT - K990639… | 2006 |
| * | K974773 | HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Standard Guide…Summary page 1….1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi Treasure Guide Wire - K061 984 Guidant Hi-Torque Floppy Guide Wire - K974773 Guidant Hi-Torque Cross-IT - K990639 Guidant Hi-Torque Steel Core 18 - K982876… | 1998 |
| * | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…Summary page 1…EVICE: Asahi Treasure Guide Wire - K061 984 Guidant Hi-Torque Floppy Guide Wire - K974773 Guidant Hi-Torque Cross-IT - K990639 Guidant Hi-Torque Steel Core 18 - K982876 Asahi PTCA Guide Wire - K052339 DESCRI… | 1999 |
| * | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Summary page 1…Guidant Hi-Torque Floppy Guide Wire - K974773 Guidant Hi-Torque Cross-IT - K990639 Guidant Hi-Torque Steel Core 18 - K982876 Asahi PTCA Guide Wire - K052339 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi… | 1998 |
| * | K052339 | Asahi Ptca Guide WireSummary page 1…Guidant Hi-Torque Cross-IT - K990639 Guidant Hi-Torque Steel Core 18 - K982876 Asahi PTCA Guide Wire - K052339 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi peripheral guide wire is a steerable guide wire with a… | 2005 |
What descends from it? (27)
See all 277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103057 | Asahi Astato XS 20 Peripheral Guide Wire | 2010 | 21 |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | 2015 | 16 |
| K153443 | ASAHI Astato XS 40 | 2016 | 14 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K172315 | Straub Endovascular System Class I | 2018 | 2 |
| K112381 | HI Torque Connect Guidewire | 2011 | 1 |
| K241962 | Crossloop | 2025 | 0 |
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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K103057 (Asahi Intecc Co., Ltd., 2010) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K061984.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 30 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/K071721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071721
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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