510(k) Report

510(k) · Cleared

Cleared

Zoom 14 Guidewire

K201760510(k) SpecialCleared Jul 29, 202030-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

Scientia Vascular, LLC · DQX Wire, Guide, Catheter

Cleared on Jul 29, 2020 as substantially equivalent to K173235 (Scientia Vascular, LLC, 2018) after a 30-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.

Decided
Jul 29, 2020
Review
30 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K002212 (2000). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2025: 2 descendants cleared2023: 1 descendant cleared2026: 3 descendants clearedK002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 2000K032146 · PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires · Precision Vascular Systems, Inc. · 2003 · recalledK173235 · Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile · Scientia Vascular, LLC · 2018200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants K173235 · Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile · Scientia Vascular, LLC · 2018K032146 · PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires · Precision Vascular Systems, Inc. · 2003 · recalledK002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 20000
  1. Root · 3 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
  2. 2 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
  3. 1 generation backK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
  4. This deviceK201760 Zoom 14 GuidewireScientia Vascular, LLC · 2020
  5. Descendant · cites it directly · 2 of its ownK243938 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, Inc. · 2025
  6. Descendant · cites it directly · 1 of its ownK220398 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, LLC · 2023
  7. Descendant · 2 generations on · 0 of its ownK260223 Aristotle Mini GuidewireScientia Vascular, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK253579 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, Inc. · 2026
  9. Descendant · 2 generations on · 0 of its ownK252317 Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2023: 12025: 22026: 3
2023high 3 (2026) · low 0 (2024)2026

Most influential descendants

Showing 5 of 6 · See all
  • K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc. · 2025 · cites it directly2descendants
  • K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC · 2023 · cites it directly1descendant
  • K260223Aristotle Mini GuidewireScientia Vascular, Inc. · 2026 · 2 generations on0descendants
  • K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc. · 2026 · cites it directly0descendants
  • K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002212Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc.2000—
−2K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc.20031
−1K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm…Scientia Vascular, LLC2018—
0 (this device)K201760Zoom 14 GuidewireScientia Vascular, LLC2020—
+1K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom…Scientia Vascular, Inc.2025—
+1K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo…Scientia Vascular, LLC2023—
+2K260223Aristotle Mini GuidewireScientia Vascular, Inc.2026—
+1K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom…Scientia Vascular, Inc.2026—
+2K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202520
202630
FIG. 1 — Lineage of K201760, 2000–2026Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…
Summary page 4
…atheter Guide Wire per 21 CFR 870.1330 Primary Product Code: DQX Secondary Product Code MOF Predicate Device: Aristotle 14 Guidewire (K173235) Pg. 1 Scientia Vascular LLC Speci…
Scientia Vascular, LLC2018—

Also cleared against K173235: 5 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20252
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20260

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 20 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K243938 (Scientia Vascular, Inc., 2025) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate K173235.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

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 Zoom 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K173235

5 other devices cite the same predicate.

  • K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc. · 2026
  • K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle…Scientia Vascular, Inc. · 2025
  • K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14…Scientia Vascular, LLC · 2023
  • K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
  • K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire…Scientia Vascular, LLC · 2018

More from Scientia Vascular, LLC

10 FDA decisions under this applicant name. See the company

  • K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14…Scientia Vascular, LLC · 2023
  • K210601Plato 17 MicrocatheterScientia Vascular, LLC · 20211 recall
  • K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
  • K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
  • K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire…Scientia Vascular, LLC · 2018

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/K201760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201760: Zoom 14 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201760

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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