510(k) · Cleared
ClearedASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
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 Oct 6, 2016 as substantially equivalent to K113716 (Asahi Intecc Co., Ltd., 2012) after a 120-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Oct 6, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K890505 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 backK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- 1 generation backK113716 Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd. · 2012
- This deviceK161584 ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd. · 2016
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 | K110584 | Asahi Chikai Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| −1 | K113716 | Asahi Chikai V Peripheral Vascular Guide Wire | Asahi Intecc Co., Ltd. | 2012 | — |
| 0 (this device) | K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 | Asahi Intecc Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K113716 | Asahi Chikai V Peripheral Vascular Guide WireSummary page 4…UCT CODE DQX- Catheter Guide Wire PREDICATE DEVICES: ASAHI® Peripheral Vascular Guide Wire: ASAHI® CHIKAI® V (K113716) REFERENCE DEVICES: • ASAHI® PTCA Guide Wire: ASAHI Fielder (K052022, K062186)… | 2012 |
| † | K052022 | Asahi Ptca Guide Wire Fielder | 2005 |
| † | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | 2006 |
| † | K072705 | Asahi Ptca Guide Wire, Fielder FC J, Models: AGP140001J, AGP140301J | 2007 |
| † | K141751 | Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi… | 2015 |
| † | K111485 | Fathom 16 Steerable Guidewire Model M001509XXX | 2011 |
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 27 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161584: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161584
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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