510(k) · Cleared
ClearedVascupuncture Picc Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neometrics, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 30, 2003 as substantially equivalent to K012861 (Neometrics, Inc., 2002) and 1 other predicate after a 125-day review. Its family tree reaches back 2 generations to 2001. 12 later devices descend from it.
- Decided
- Sep 30, 2003
- Review
- 125 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011084 (2001). 4 ancestors in all, the oldest K971322 (1998). 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 1 generation backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- This deviceK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014
- Descendant · 4 generations on · 2 of its ownK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004 · cites it directly11descendants
- K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005 · cites it directly10descendants
- K112631Vsi GuidewireVascular Solutions, Inc. · 2011 · 2 generations on7descendants
- K133114Micropuncture Introducer SetCook Incorporated · 2014 · 3 generations on4descendants
- K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −1 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| 0 (this device) | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| +1 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| +1 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| +2 | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| +3 | K133114 | Micropuncture Introducer Set | Cook Incorporated | 2014 | — |
| +4 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus… | Cook Incorporated | 2017 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012861 | Vascupuncture Access WireSummary page 1…e Wire, Guide, Catheter and Number: 870.1330 ~ ~ Product Code: DQX Predicate Device(s): VascuPuncture Access Wire, 5 10(k) number K012861, and Selectiva Guidewire cleared via the 5 10(k) KO 13024. Device Description: The VascuPuncture PICC… | 2002 |
| * | K013024 | Selectiva Guidewire | 2001 |
What descends from it? (12)
See all 123 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 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040786 (Neometrics, Inc., 2004) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031652: Vascupuncture Picc Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031652
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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