510(k) Report

510(k) · Cleared

Cleared

Nitrex Nitinol Guidewire

K024021510(k) SpecialCleared Jan 24, 200350-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

Ev3 Corporation · DQX Wire, Guide, Catheter

Cleared on Jan 24, 2003 as substantially equivalent to K910280 (Microvena Corp., 1991) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1991. 5 of the 52 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.

Decided
Jan 24, 2003
Review
50 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K910280 (1991). 2 ancestors in all. 49 later devices descend from it, 3 citing it directly. 5 of the 52 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2003: 1 descendant cleared2005: 1 descendant cleared2004: 1 descendant cleared2007: 1 descendant cleared2016: 2 descendants cleared2006: 1 descendant cleared2011: 2 descendants cleared2010: 4 descendants cleared2009: 4 descendants cleared2012: 8 descendants cleared2013: 1 descendant cleared2026: 4 descendants cleared2014: 4 descendants cleared2015: 1 descendant cleared2019: 2 descendants cleared, 1 with a Class I recall12018: 1 descendant cleared2024: 3 descendants cleared, 2 with a Class I recall22023: 3 descendants cleared, 1 with a Class I recall12025: 4 descendants cleared, 1 with a Class I recall12021: 1 descendant clearedK910280 · Ultra-Select Ptca Guidewire · Microvena Corp. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 5 descendants, 1 with a Class I recall17 generations forward: 5 descendants, 4 with a Class I recall48 generations forward: 5 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants K910280 · Ultra-Select Ptca Guidewire · Microvena Corp. · 19910+5+10
  1. Root · 1 generation backK910280 Ultra-Select Ptca GuidewireMicrovena Corp. · 1991
  2. This deviceK024021 Nitrex Nitinol GuidewireEv3 Corporation · 2003
  3. Descendant · cites it directly · 48 of its ownK031864 Nitrex Nitinol GuidewireEv3 Corporation · 2003
  4. Descendant · 2 generations on · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
  5. Descendant · 3 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
  6. Descendant · 4 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
  7. Descendant · 4 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12006: 12007: 12009: 42010: 42011: 22012: 82013: 12014: 42015: 12016: 22018: 12019: 22021: 12023: 32024: 32025: 42026: 4
2003high 8 (2012) · low 0 (2008)2026

Class I recalls in this family

  • K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
  • K230309 Intra-Operative Positioning System (IOPS®)…7 generations on · 2023

Most influential descendants

Showing 5 of 49 · See all
  • K031864Nitrex Nitinol GuidewireEv3 Corporation · 2003 · cites it directly48descendants
  • K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · 2 generations on35descendants
  • K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 3 generations on30descendants
  • K110256The IC-Pro SystemPaieon, Inc. · 2011 · 4 generations on15descendants
  • K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910280Ultra-Select Ptca GuidewireMicrovena Corp.1991—
0 (this device)K024021Nitrex Nitinol GuidewireEv3 Corporation2003—
+1K031864Nitrex Nitinol GuidewireEv3 Corporation2003—
+2K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC2007—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.2009—
+4K110256The IC-Pro SystemPaieon, Inc.2011—
+4K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200610
200710
200940
201040
201120
201280
201310
201440
201510
201620
201810
201921
202110
202331
202432
202541
202640
FIG. 1 — Lineage of K024021, 1991–2026Source: 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.

5 devices in this family have a Class I recall. 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
*K910280Ultra-Select Ptca Guidewire
Summary page 1
…Phil Neururer Regulatory Affairs 763-398-7094 PREDICATE Ultra-Select guidewire (K9 10280) FlexFinder guidewire (€3393626, K943390) DEVICE The guidewire is constructed…
Microvena Corp.1991—
*K943390Flexfinder Guidewire
Summary page 1
…irs 763-398-7094 PREDICATE Ultra-Select guidewire (K9 10280) FlexFinder guidewire (€3393626, K943390) DEVICE The guidewire is constructed of nitinol (nickel-titanium DESCRIPTION alloy). The n…
Flexmedics1995—

Also cleared against K910280: 2 other devices →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K031864Nitrex Nitinol GuidewireEv3 Corporation200348
K040345Modification to Nitrex Nitinol GuidewireEv3, Inc.200411
K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L.200510

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K031864 (Ev3 Corporation, 2003) has gone furthest, with 48 descendants of its own.
  • 2 other devices also cite its predicate K910280.

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 0.035” and 0.025” Guidewire is indicated for use in the peripheral vasculature. The 0.014”, 0.016”, and 0.018” guidewires are indicated for use in the peripheral and coronary vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K910280

2 other devices cite the same predicate.

  • K031864Nitrex Nitinol GuidewireEv3 Corporation · 2003
  • K990823PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999

More from Ev3 Corporation

5 FDA decisions under this applicant name. See the company

  • K051379Protege RX GPS Self-Expanding Nitrinol StentEv3 Corporation · 2005
  • K050725Protege GPS Self-Expanding Nitinol StentEv3 Corporation · 20051 recall
  • K021096X-Sizer Catheter SystemEv3 Corporation · 20042 recalls
  • K031864Nitrex Nitinol GuidewireEv3 Corporation · 2003

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/K024021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024021: Nitrex Nitinol Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024021

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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