510(k) Report

510(k) · Cleared

Cleared

Modification to Vascupuncture Picc Guidewire

K043398510(k) SpecialCleared Mar 1, 200581-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neometrics, Inc. · DQX Wire, Guide, Catheter

Cleared on Mar 1, 2005 as substantially equivalent to K031652 (Neometrics, Inc., 2003) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 2001. 10 later devices descend from it.

Decided
Mar 1, 2005
Review
81 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K011084 (2001). 6 ancestors in all, the oldest K971322 (1998). 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor2011: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2023: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK011084 · Mandrel Guidewire Assembly · Lake Region Mfg., Inc. · 2001K013024 · Selectiva Guidewire · Neometrics, Inc. · 2001K031652 · Vascupuncture Picc Guidewire · Neometrics, Inc. · 2003K040786 · Vascupuncture Picc Guidewire with Hydro-Silk Coating · Neometrics, Inc. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K040786 · Vascupuncture Picc Guidewire with Hydro-Silk Coating · Neometrics, Inc. · 2004K031652 · Vascupuncture Picc Guidewire · Neometrics, Inc. · 2003K013024 · Selectiva Guidewire · Neometrics, Inc. · 2001K011084 · Mandrel Guidewire Assembly · Lake Region Mfg., Inc. · 20010
  1. Root · 4 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
  2. 3 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
  3. 2 generations backK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
  4. 1 generation backK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
  5. This deviceK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
  6. Descendant · cites it directly · 7 of its ownK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
  7. Descendant · 2 generations on · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014
  8. Descendant · 3 generations on · 2 of its ownK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
  9. Descendant · cites it directly · 1 of its ownK070150 Vascupuncture Picc GuidewireNeometrics, Inc. · 2007
  10. Descendant · 4 generations on · 0 of its ownK253526 NAMIC Dilator and SheathMedline Industries, LP · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12011: 12014: 12017: 12018: 12023: 22024: 12026: 1
2007high 2 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K112631Vsi GuidewireVascular Solutions, Inc. · 2011 · cites it directly7descendants
  • K133114Micropuncture Introducer SetCook Incorporated · 2014 · 2 generations on4descendants
  • K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated · 2017 · 3 generations on2descendants
  • K070150Vascupuncture Picc GuidewireNeometrics, Inc. · 2007 · cites it directly1descendant
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011084Mandrel Guidewire AssemblyLake Region Mfg., Inc.2001—
−3K013024Selectiva GuidewireNeometrics, Inc.2001—
−2K031652Vascupuncture Picc GuidewireNeometrics, Inc.2003—
−1K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc.2004—
0 (this device)K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc.2005—
+1K112631Vsi GuidewireVascular Solutions, Inc.2011—
+2K133114Micropuncture Introducer SetCook Incorporated2014—
+3K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus…Cook Incorporated2017—
+1K070150Vascupuncture Picc GuidewireNeometrics, Inc.2007—
+4K253526NAMIC Dilator and SheathMedline Industries, LP2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201110
201410
201710
201810
202320
202410
202610
FIG. 1 — Lineage of K043398, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K031652Vascupuncture Picc Guidewire
Summary page 1
…Classification Name Wire, Guide, Catheter: 21 CFR 870.1330 -and Number: -ProductCode: DQX Predicate Device VascuPuncture P1CC Guidewire, K03 1652 and K040786 Name and 510(k) -Number Device Description: DEVICE DESCRIPTION The VascuPuncture…
Neometrics, Inc.2003—
*K040786Vascupuncture Picc Guidewire with Hydro-Silk Coating
Summary page 1
…on Name Wire, Guide, Catheter: 21 CFR 870.1330 -and Number: -ProductCode: DQX Predicate Device VascuPuncture P1CC Guidewire, K03 1652 and K040786 Name and 510(k) -Number Device Description: DEVICE DESCRIPTION The VascuPunctureTrm P1CC Gui…
Neometrics, Inc.2004—

Also cleared against K031652: 2 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112631Vsi GuidewireVascular Solutions, Inc.20117
K070150Vascupuncture Picc GuidewireNeometrics, Inc.20071

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 4 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K112631 (Vascular Solutions, Inc., 2011) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K031652.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique

Indications for use as stated in the FDA summary.

Also cleared against K031652

2 other devices cite the same predicate.

  • K070150Vascupuncture Picc GuidewireNeometrics, Inc. · 2007
  • K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004

More from Neometrics, Inc.

21 FDA decisions under this applicant name. See the company

  • K152560Bard Snare Retrieval KitNeometrics, Inc. · 2015
  • K150225NovaGold High Performance GuidewireNeometrics, Inc. · 2015
  • K143135Spring Coil GuidewireNeometrics, Inc. · 2015
  • K133076Novagold High Performance GuidewireNeometrics, Inc. · 20141 recall
  • K123439Neo Ercp GuidewireNeometrics, Inc. · 2013

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K043398 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043398: Modification to Vascupuncture Picc Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043398

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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