510(k) · Cleared
ClearedRunthrough NS Extension Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DQX Wire, Guide, Catheter
Cleared on Mar 20, 2008 as substantially equivalent to K063695 (Terumo Medical Corp., 2007) after a 21-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953533 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 2 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 1 generation backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- This deviceK080563 Runthrough NS Extension WireTerumo Medical Corp. · 2008
- Descendant · cites it directly · 2 of its ownK093647 Traxcess Docking WireMicroVention, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK112219 Tapas CatheterThermopeutix, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK093397 Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK191687 pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited · 2019
- Descendant · 3 generations on · 0 of its ownK141175 Renovocath RC120Renovorx, Inc. · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K093647Traxcess Docking WireMicroVention, Inc. · 2010 · cites it directly2descendants
- K112219Tapas CatheterThermopeutix, Inc. · 2011 · 2 generations on1descendant
- K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc. · 2009 · cites it directly1descendant
- K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited · 2019 · 2 generations on0descendants
- K141175Renovocath RC120Renovorx, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −2 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −1 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| 0 (this device) | K080563 | Runthrough NS Extension Wire | Terumo Medical Corp. | 2008 | — |
| +1 | K093647 | Traxcess Docking Wire | MicroVention, Inc. | 2010 | — |
| +2 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| +1 | K093397 | Traxcess 14EX Guidewire and Traxcess Docking Wire | MicroVention, Inc. | 2009 | — |
| +2 | K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire | Phenox Limited | 2019 | — |
| +3 | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K063695 | Runthrough NSSummary page 1…angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA). Note: This is the same intended use as the predicate device - Runthrough NS K063695 C. Device Description The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a… | 2007 |
What descends from it? (5)
2 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 13 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K093647 (MicroVention, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K063695.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Runthrough NS Extension Wire are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080563 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080563: Runthrough NS Extension Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080563
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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