510(k) · Cleared
ClearedVsi Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQX Wire, Guide, Catheter
Cleared on Oct 27, 2011 as substantially equivalent to K043398 (Neometrics, Inc., 2005) after a 48-day review. Its family tree reaches back 5 generations to 2001. 7 later devices descend from it.
- Decided
- Oct 27, 2011
- Review
- 48 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011084 (2001). 7 ancestors in all, the oldest K971322 (1998). 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 4 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- 3 generations backK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- 2 generations backK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- 1 generation backK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- This deviceK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014
- Descendant · 2 generations on · 2 of its ownK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK253526 NAMIC Dilator and SheathMedline Industries, LP · 2026
- Descendant · 3 generations on · 0 of its ownK240589 Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024
- Descendant · cites it directly · 0 of its ownK223791 TalWireEmbrace Medical, Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133114Micropuncture Introducer SetCook Incorporated · 2014 · cites it directly4descendants
- K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated · 2017 · 2 generations on2descendants
- K253526NAMIC Dilator and SheathMedline Industries, LP · 2026 · 3 generations on0descendants
- K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024 · 3 generations on0descendants
- K223791TalWireEmbrace Medical, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −4 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| −3 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| −2 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| −1 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| 0 (this device) | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| +1 | K133114 | Micropuncture Introducer Set | Cook Incorporated | 2014 | — |
| +2 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus… | Cook Incorporated | 2017 | — |
| +3 | K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026 | — |
| +3 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical | 2024 | — |
| +1 | K223791 | TalWire | Embrace Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012861 | FDA’s K012861 is Vascupuncture Access Wire Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K043398 | Modification to Vascupuncture Picc GuidewireSummary page 1…ng the catheter _________________through a blood vessel. Predicate Device(s) VascuPunctureTM P1CC Guidewire (KO 1286] and K043398, Neometrics, Inc.) Devie Description The VSI Guidewire is available in a diameter of… | 2005 |
What descends from it? (7)
3 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 10 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K133114 (Cook Incorporated, 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K043398.
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 VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112631: Vsi Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112631
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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