510(k) · Cleared
ClearedRadifocus Glidewire Advantage Track
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ashitaka Factory of Terumo Coporation · DQX Wire, Guide, Catheter
Cleared on Jan 30, 2017 as substantially equivalent to K122590 (Terumo Medical Corporation, 2013) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jan 30, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863138 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 2 generations backK063372 Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007
- 1 generation backK122590 Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation · 2013
- This deviceK163004 Radifocus Glidewire Advantage TrackAshitaka Factory of Terumo Coporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −2 | K063372 | Radifocus Glidewire Advantage | Terumo Medical Corp. | 2007 | — |
| −1 | K122590 | Radifocus Glidewire Advantage, Radifocus Glidewire Advantage | Terumo Medical Corporation | 2013 | — |
| 0 (this device) | K163004 | Radifocus Glidewire Advantage Track | Ashitaka Factory of Terumo Coporation | 2017 | — |
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? (2)
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 |
|---|---|---|---|
| * | K122590 | Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageSummary page 5…DQX Classification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed are: K122590 and K063372 - Radifocus Glidewire Advantage manufactured by Ashitaka Factory of Terumo Corporation. The following c… | 2013 |
| * | K063372 | Radifocus Glidewire AdvantageSummary page 5…lassification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed are: K122590 and K063372 - Radifocus Glidewire Advantage manufactured by Ashitaka Factory of Terumo Corporation. The following competitors’… | 2007 |
| † | K033742 | Boston Scientific V-18 Control Wire | 2004 |
| † | K112745 | V-14 Control Wire Guidewire | 2011 |
| † | K052339 | Asahi Ptca Guide Wire | 2005 |
| † | K122573 | HI-Torque Command Guide Wire Family | 2012 |
| † | K152709 | HI-Torque Balance | 2015 |
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 31 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 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. 2017, 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 Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163004: Radifocus Glidewire Advantage Track.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163004
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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