510(k) Report

510(k) · Cleared

Cleared

Radifocus Glidewire GT with Gold Coil,Glidewire Gold

K955801510(k) TraditionalCleared Feb 2, 199642-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

Terumo Medical Corp. · DQX Wire, Guide, Catheter

Cleared on Feb 2, 1996 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided
Feb 2, 1996
Review
42 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2014: 1 descendant cleared2009: 1 descendant cleared2019: 1 descendant cleared2020: 3 descendants cleared2015: 1 descendant cleared2026: 2 descendants cleared2018: 1 descendant cleared2016: 2 descendants cleared1995200020052010201520202025
  1. This deviceK955801 Radifocus Glidewire GT with Gold Coil,Glidewire GoldTerumo Medical Corp. · 1996
  2. Descendant · cites it directly · 12 of its ownK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
  3. Descendant · 2 generations on · 9 of its ownK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
  4. Descendant · 3 generations on · 4 of its ownK153053 Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015
  5. Descendant · 4 generations on · 2 of its ownK161803 Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK182337 HYBRID GuidewireBalt USA, LLC · 2018

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22009: 12014: 12015: 12016: 22018: 12019: 12020: 32026: 2
2005high 3 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all
  • K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008 · cites it directly12descendants
  • K133725Traxcess 14 GuidewireMicroVention, Inc. · 2014 · 2 generations on9descendants
  • K153053Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015 · 3 generations on4descendants
  • K161803Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · 4 generations on2descendants
  • K182337HYBRID GuidewireBalt USA, LLC · 2018 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955801Radifocus Glidewire GT with Gold Coil,Glidewire GoldTerumo Medical Corp.1996—
+1K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.2008—
+2K133725Traxcess 14 GuidewireMicroVention, Inc.2014—
+3K153053Traxcess Pro 14 GuidewireMicroVention, Inc.2015—
+4K161803Traxcess .007 Mini GuidewireMicroVention, Inc.20161
+3K182337HYBRID GuidewireBalt USA, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
200910
201410
201510
201620
201810
201910
202030
202620
FIG. 1 — Lineage of K955801, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812
K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc.20051

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?

  • Of its descendants, K080863 (MicroVention, Inc., 2008) has gone furthest, with 12 descendants of its own.

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)—

More from Terumo Medical Corp.

143 FDA decisions under this applicant name. See the company

  • K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 20111 recall
  • K111556Glidecross Support CatheterTerumo Medical Corp. · 2011
  • K110540Terumo Support CatheterTerumo Medical Corp. · 2011
  • K102008GlidesheathTerumo Medical Corp. · 20101 recall
  • K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 20091 recall

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The DQX category page

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https://510kreport.com/device/K955801 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955801: Radifocus Glidewire GT with Gold Coil,Glidewire Gold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955801

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026