510(k) · Cleared
Recalled · 2011Runthrough NS
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 Apr 27, 2007 as substantially equivalent to K961445 (Terumo Medical Corp., 1996) after a 135-day review. Its family tree reaches back 2 generations to 1995. 31 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 2007
- Review
- 135 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953533 (1995). 31 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 1 generation backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- This deviceK063695 Runthrough NSTerumo Medical Corp. · 2007
- Descendant · cites it directly · 13 of its ownK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
- Descendant · cites it directly · 12 of its ownK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
- Descendant · 2 generations on · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011 · cites it directly13descendants
- K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008 · cites it directly12descendants
- K133725Traxcess 14 GuidewireMicroVention, Inc. · 2014 · 2 generations on9descendants
- K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011 · 2 generations on7descendants
- K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −1 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| 0 (this device) | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | — |
| +1 | K103101 | HI-Torque Balance Middleweight Elite | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +1 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| +2 | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| +2 | K112957 | HI-Torque Powerturn | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +2 | K122573 | HI-Torque Command Guide Wire Family | Abbott Vascular, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilSummary page 1…luminal angioplasty (PTA). Note: This is the same intended use as the predicate device - Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445. C. Device Description The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire,… | 1996 |
What descends from it? (31)
See all 313 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2011 | Not classified | Z-2858-2011 | Device Design | Baloon catheter guidewires may become uncoiled during angioplasty procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103101 (Abbott Vascular-Cardiac Therapies, 2011) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K961445.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Runthrouh NS are used to facilitate 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/K063695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063695: Runthrough NS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063695
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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