510(k) · Cleared
ClearedVascupuncture Access Wire
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 5, 2002 as substantially equivalent to K971322 (Lake Region Mfg., Inc., 1998) after a 165-day review. Its family tree reaches back 1 generation to 1998. 13 later devices descend from it.
- Decided
- Feb 5, 2002
- Review
- 165 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971322 (1998). 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971322 Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1998
- This deviceK012861 Vascupuncture Access WireNeometrics, Inc. · 2002
- Descendant · cites it directly · 12 of its ownK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- Descendant · 2 generations on · 11 of its ownK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- Descendant · 2 generations on · 10 of its ownK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- Descendant · 3 generations on · 7 of its ownK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K031652Vascupuncture Picc GuidewireNeometrics, Inc. · 2003 · cites it directly12descendants
- K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004 · 2 generations on11descendants
- K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005 · 2 generations on10descendants
- K112631Vsi GuidewireVascular Solutions, Inc. · 2011 · 3 generations on7descendants
- K133114Micropuncture Introducer SetCook Incorporated · 2014 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971322 | Core and Coil Assembly Guidewire | Lake Region Mfg., Inc. | 1998 | — |
| 0 (this device) | K012861 | Vascupuncture Access Wire | Neometrics, Inc. | 2002 | — |
| +1 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| +2 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| +2 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| +3 | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| +4 | K133114 | Micropuncture Introducer Set | Cook Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K971322 | Core and Coil Assembly GuidewireSummary page 1…ire, catheter guidewire, and wire guide Trade/Proprietary Name: Vascupuncture™ Access Wire Substantially Equivalent Products: Lake Region Manufacturing CCA Guidewires (K971322) and other commercially distributed devices. Description: This guidewire has a 0.0175” diameter and is available in lengths of 4… | 1998 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031652 | Vascupuncture Picc Guidewire | 2003 | 12 |
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?
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?
For percutaneous vascular entry using the Seldinger technique.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012861: Vascupuncture Access Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012861
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026