510(k) Report

510(k) · Cleared

Cleared

Radifocus Glidewire Advantage

K063372510(k) SpecialCleared Jan 19, 200772-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 Jan 19, 2007 as substantially equivalent to K863138 (Terumo Medical Corp., 1986) after a 72-day review. Its family tree reaches back 1 generation to 1986. 7 later devices descend from it.

Decided
Jan 19, 2007
Review
72 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K863138 (1986). 7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedK863138 · Terumo Radifocus Guide Wire · Terumo Medical Corp. · 19861990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants K863138 · Terumo Radifocus Guide Wire · Terumo Medical Corp. · 19860
  1. Root · 1 generation backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
  2. This deviceK063372 Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007
  3. Descendant · cites it directly · 1 of its ownK213315 CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd. · 2022
  4. Descendant · cites it directly · 1 of its ownK122590 Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation · 2013
  5. Descendant · cites it directly · 1 of its ownK113162 Slidewiretm (Trademark Pending)Acme-Monaco Corp. · 2012
  6. Descendant · 2 generations on · 0 of its ownK261281 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  7. Descendant · 2 generations on · 0 of its ownK193653 Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12017: 12020: 12022: 12026: 1
2012high 1 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K213315CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd. · 2022 · cites it directly1descendant
  • K122590Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation · 2013 · cites it directly1descendant
  • K113162Slidewiretm (Trademark Pending)Acme-Monaco Corp. · 2012 · cites it directly1descendant
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026 · 2 generations on0descendants
  • K193653Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863138Terumo Radifocus Guide WireTerumo Medical Corp.1986—
0 (this device)K063372Radifocus Glidewire AdvantageTerumo Medical Corp.2007—
+1K213315CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd.2022—
+1K122590Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation2013—
+1K113162Slidewiretm (Trademark Pending)Acme-Monaco Corp.2012—
+2K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.2026—
+2K193653Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201710
202010
202210
202610
FIG. 1 — Lineage of K063372, 1986–2026Source: 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? (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
*K863138Terumo Radifocus Guide Wire
Summary page 1
…anatomical location during diagnostic or interventional procedures. Note: This is the same intended use as the predicate device - Radifocus Guide Wire K863138 C. Device Description The Radifocus Glidewire Advantage consists of a Nickel Titanium alloy core wire. A polyuretha…
Terumo Medical Corp.1986—

Also cleared against K863138: 11 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K213315CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd.20221
K122590Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation20131
K113162Slidewiretm (Trademark Pending)Acme-Monaco Corp.20121
K163004Radifocus Glidewire Advantage TrackAshitaka Factory of Terumo Coporation20170
K141707Ultraskin Hydrophilic Guide WireLepu Medical Technology (Beijing) Co., Ltd.20150

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?

  • Its one ancestor has no recall.
  • Of its descendants, K213315 (Asahi Intecc Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
  • 11 other devices also cite its predicate K863138.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

Indications for use as stated in the FDA summary.

Also cleared against K863138

11 other devices cite the same predicate.

  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K172187Inno-HydrowireSuzhou Innomed Medical Device Co., Ltd. · 2018
  • K170417Glidewire GTTerumo Corporation · 2017
  • K160594MRWire Guide WireNano4imaging GmbH · 2016
  • K152740Radifocus GlidewireAshitaka Factory of Terumo Corp. · 2015
  • K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013

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

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/K063372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063372: Radifocus Glidewire Advantage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063372

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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