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 Feb 15, 2007 as substantially equivalent to K031652 (Neometrics, Inc., 2003) and 2 other predicates after a 30-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Feb 15, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K011084 (2001). 7 ancestors in all, the oldest K971322 (1998). 1 later device descends from it, 1 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 deviceK070150 Vascupuncture Picc GuidewireNeometrics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK101729 Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101729Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010 · 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) | K070150 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2007 | — |
| +1 | K101729 | Neowire Pta/Ptca Guidewire | Neometrics, Inc. | 2010 | — |
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 |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K031652 | Vascupuncture Picc GuidewireSummary page 1…eTM PICC Guidewire Classification Name Wire, Guide, Catheter: 21 CFR 870.1330 and Number: Product Code: DQX Predicate Device VascuPuncture PICC Guidewire, K031652, K040786, K043398 Name and 510(k) Number Device Description: DEVICE DESCRIPTION The VascuPunctureTM PICC… | 2003 |
| * | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk CoatingSummary page 1…Guidewire Classification Name Wire, Guide, Catheter: 21 CFR 870.1330 and Number: Product Code: DQX Predicate Device VascuPuncture PICC Guidewire, K031652, K040786, K043398 Name and 510(k) Number Device Description: DEVICE DESCRIPTION The VascuPunctureTM PICC Guidewire… | 2004 |
| * | K043398 | Modification to Vascupuncture Picc GuidewireSummary page 1…Classification Name Wire, Guide, Catheter: 21 CFR 870.1330 and Number: Product Code: DQX Predicate Device VascuPuncture PICC Guidewire, K031652, K040786, K043398 Name and 510(k) Number Device Description: DEVICE DESCRIPTION The VascuPunctureTM PICC Guidewires are gui… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101729 | Neowire Pta/Ptca Guidewire | 2010 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K101729 (Neometrics, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031652.
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 VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070150: Vascupuncture Picc Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070150
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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