510(k) · Cleared
ClearedASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
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 Jun 30, 2015 as substantially equivalent to K083146 (Asahi Intecc Co., Ltd., 2008) and 2 other predicates after a 130-day review. Its family tree reaches back 10 generations to 1989. 16 later devices descend from it.
- Decided
- Jun 30, 2015
- Review
- 130 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K890505 (1989). 28 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations between
- 3 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 2 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 1 generation backK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- This deviceK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK203533 Vassallo GTFilmecc Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK213868 ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK212268 FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension…FMD Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK203529 VASSALLO GT HybridFilmecc Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 8 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 7 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 6 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 5 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 4 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 3 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 2 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 1 generation backK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- This deviceK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. · 2017 · cites it directly11descendants
- K203533Vassallo GTFilmecc Co., Ltd. · 2021 · cites it directly3descendants
- K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd. · 2022 · cites it directly1descendant
- K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd. · 2022 · cites it directly1descendant
- K203529VASSALLO GT HybridFilmecc Co., Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −9 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −8 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −7 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −6 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −5 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −4 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −3 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −2 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| −1 | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
| 0 (this device) | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
| +1 | K203533 | Vassallo GT | Filmecc Co., Ltd. | 2021 | — |
| +1 | K213868 | ASAHI Gladius Mongo18 PV ES | Asahi Intecc Co., Ltd. | 2022 | — |
| +1 | K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | FMD Co., Ltd. | 2022 | — |
| +1 | K203529 | VASSALLO GT Hybrid | 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Summary page 4…uide, Wire NAME: PRODUCT CODE DQX- Catheter Guide Wire PREDICATE Primary Predicates: DEVICES: ASAHI Regalia XS 1.0 Peripheral Guide Wire (K083146) ASAHI ASTATO 30 Peripheral Guide Wire 10 (K071721) ASAHI ASTATO XS20 Peripheral Guide… | 2008 |
| * | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Summary page 4…TE Primary Predicates: DEVICES: ASAHI Regalia XS 1.0 Peripheral Guide Wire (K083146) ASAHI ASTATO 30 Peripheral Guide Wire 10 (K071721) ASAHI ASTATO XS20 Peripheral Guide Wire (K103057) Reference Devices:… | 2007 |
| * | K103057 | Asahi Astato XS 20 Peripheral Guide WireSummary page 4…1.0 Peripheral Guide Wire (K083146) ASAHI ASTATO 30 Peripheral Guide Wire 10 (K071721) ASAHI ASTATO XS20 Peripheral Guide Wire (K103057) Reference Devices: ASAHI PTCA Guide Wire ASAHI Gaia Third (K133865)… | 2010 |
| † | K133865 | Asahi Gaia First, Second, Third | 2014 |
| † | K963702 | Acs HI-Torque Iron Man Guide Wire | 1997 |
| † | K033742 | Boston Scientific V-18 Control Wire | 2004 |
| † | K112979 | Asahi Chikai 10 Neurovascular Guide Wire | 2011 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K203533 | Vassallo GT | 2021 | 3 |
| K213868 | ASAHI Gladius Mongo18 PV ES | 2022 | 1 |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | 2022 | 1 |
| K203529 | VASSALLO GT Hybrid | 2021 | 1 |
| K241702 | CROSSLEAD 0.014inch | 2025 | 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 26 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K163426 (Asahi Intecc Co., Ltd., 2017) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K083146.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This product 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/K150445 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150445
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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