510(k) Report

510(k) · Cleared

Cleared

Terumo Radifocus Guide Wire

K863138510(k) TraditionalCleared Nov 20, 198697-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 Nov 20, 1986 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 37 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it.

Decided
Nov 20, 1986
Review
97 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

36 later devices descend from it, 12 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2016: 1 descendant cleared2013: 4 descendants cleared2015: 2 descendants cleared2009: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared2012: 3 descendants cleared, 1 with a Class I recall12006: 1 descendant cleared2017: 4 descendants cleared2018: 1 descendant cleared2026: 4 descendants cleared2008: 1 descendant cleared2022: 1 descendant cleared2020: 3 descendants cleared2014: 1 descendant cleared2024: 4 descendants cleared2023: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
  2. Descendant · cites it directly · 9 of its ownK092303 Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · Recalled
  3. Descendant · cites it directly · 8 of its ownK152740 Radifocus GlidewireAshitaka Factory of Terumo Corp. · 2015
  4. Descendant · 2 generations on · 8 of its ownK120644 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · Recalled
  5. Descendant · cites it directly · 7 of its ownK063372 Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007
  6. Descendant · 3 generations on · 6 of its ownK130588 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12009: 12012: 32013: 42014: 12015: 22016: 12017: 42018: 12020: 32022: 12023: 12024: 42025: 22026: 4
2005high 4 (2013) · low 0 (2010)2026

Class I recalls in this family

  • K121398 Charlie Guidewire (Regular), Charlie Guidewire…cites it directly · 2012

Most influential descendants

Showing 5 of 36 · See all
  • K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · cites it directly9descendants
  • K152740Radifocus GlidewireAshitaka Factory of Terumo Corp. · 2015 · cites it directly8descendants
  • K120644Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · 2 generations on8descendants
  • K063372Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007 · cites it directly7descendants
  • K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863138Terumo Radifocus Guide WireTerumo Medical Corp.1986—
+1K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc.20096
+1K152740Radifocus GlidewireAshitaka Factory of Terumo Corp.2015—
+2K120644Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20122
+1K063372Radifocus Glidewire AdvantageTerumo Medical Corp.2007—
+3K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
200910
201231
201340
201410
201520
201610
201740
201810
202030
202210
202310
202440
202520
202640
FIG. 1 — Lineage of K863138, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has 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?

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

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc.20099
K152740Radifocus GlidewireAshitaka Factory of Terumo Corp.20158
K063372Radifocus Glidewire AdvantageTerumo Medical Corp.20077
K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20135
K160594MRWire Guide WireNano4imaging GmbH20162
K170417Glidewire GTTerumo Corporation20171
K113162Slidewiretm (Trademark Pending)Acme-Monaco Corp.20121
K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc.20051
K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.20260
K172187Inno-HydrowireSuzhou Innomed Medical Device Co., Ltd.20180

Has anything in its family been recalled? (1 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.

  • K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls

What does this lineage say?

  • Of its descendants, K092303 (Merit Medical Systems, Inc., 2009) has gone furthest, with 9 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

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/K863138 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863138: Terumo Radifocus Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863138

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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