510(k) · Cleared
ClearedAsahi Guide Wire Extension 165CM
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 Mar 7, 2011 as substantially equivalent to K083145 (Asahi Intecc Co., Ltd., 2009) after a 236-day review. Its family tree reaches back 6 generations to 1989. 13 later devices descend from it.
- Decided
- Mar 7, 2011
- Review
- 236 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K890505 (1989). 17 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK061984 TreasureAsahi Intecc Co., Ltd. · 2006
- 1 generation backK083145 Asahi Guide Wire Extension, Model AG149000Asahi Intecc Co., Ltd. · 2009
- This deviceK101985 Asahi Guide Wire Extension 165CMAsahi Intecc Co., Ltd. · 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
- Descendant · 2 generations on · 1 of its ownK203529 VASSALLO GT HybridFilmecc Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK243733 SION blue PLUSAsahi Intecc Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241962 CrossloopAsahi Intecc Co., Ltd. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · 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 · 2 generations on3descendants
- K203529VASSALLO GT HybridFilmecc Co., Ltd. · 2021 · 2 generations on1descendant
- K243733SION blue PLUSAsahi Intecc Co., Ltd. · 2025 · 2 generations on0descendants
- K241962CrossloopAsahi Intecc Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K061984 | Treasure | Asahi Intecc Co., Ltd. | 2006 | — |
| −1 | K083145 | Asahi Guide Wire Extension, Model AG149000 | Asahi Intecc Co., Ltd. | 2009 | — |
| 0 (this device) | K101985 | Asahi Guide Wire Extension 165CM | Asahi Intecc Co., Ltd. | 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 | — |
| +2 | K203529 | VASSALLO GT Hybrid | Filmecc Co., Ltd. | 2021 | — |
| +2 | K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025 | — |
| +2 | K241962 | Crossloop | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K083145 | Asahi Guide Wire Extension, Model AG149000Summary page 1…Wire, Guide, Catheter DEVICE Class 2 per 21 CFR §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi Guide Wire Extension - 510(k) K083145 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi Guide Wire Extension (Asahi Extension Wire) accessory is… | 2009 |
What descends from it? (13)
See all 132 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 22 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 17 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.
- 1 other device also cites its predicate K083145.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101985: Asahi Guide Wire Extension 165CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101985
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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