510(k) Report

510(k) · Cleared

Cleared

Mandrel Guidewire Assembly

K011084510(k) SpecialCleared May 10, 200130-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

Lake Region Mfg., Inc. · DQX Wire, Guide, Catheter

Cleared on May 10, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.

Decided
May 10, 2001
Review
30 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

81 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2014: 6 descendants cleared2004: 3 descendants cleared2008: 3 descendants cleared2001: 1 descendant cleared2003: 3 descendants cleared2009: 2 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2007: 2 descendants cleared2005: 1 descendant cleared2017: 4 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2024: 5 descendants cleared2019: 5 descendants cleared2018: 9 descendants cleared2016: 1 descendant cleared2020: 8 descendants cleared2023: 5 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2025: 4 descendants cleared2026: 4 descendants cleared200020052010201520202025
  1. This deviceK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
  2. Descendant · cites it directly · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
  3. Descendant · 2 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
  4. Descendant · cites it directly · 15 of its ownK013024 Selectiva GuidewireNeometrics, Inc. · 2001
  5. Descendant · 2 generations on · 12 of its ownK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
  6. Descendant · 3 generations on · 11 of its ownK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2001: 12003: 32004: 32005: 12007: 22008: 32009: 22010: 12011: 22012: 12013: 12014: 62015: 22016: 12017: 42018: 92019: 52020: 82021: 42022: 42023: 52024: 52025: 42026: 4
2001high 9 (2018) · low 0 (2002)2026

Most influential descendants

Showing 5 of 81 · See all
  • K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · cites it directly51descendants
  • K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 2 generations on35descendants
  • K013024Selectiva GuidewireNeometrics, Inc. · 2001 · cites it directly15descendants
  • K031652Vascupuncture Picc GuidewireNeometrics, Inc. · 2003 · 2 generations on12descendants
  • K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011084Mandrel Guidewire AssemblyLake Region Mfg., Inc.2001—
+1K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction…Genesis Medical Interventional, Inc.2004—
+2K143563Infusion Aspiration Catheter SystemInari Medical, Inc.2015—
+1K013024Selectiva GuidewireNeometrics, Inc.2001—
+2K031652Vascupuncture Picc GuidewireNeometrics, Inc.2003—
+3K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200330
200430
200510
200720
200830
200920
201010
201120
201210
201310
201460
201520
201610
201740
201890
201950
202080
202140
202240
202350
202450
202540
202640
FIG. 1 — Lineage of K011084, 2001–2026Source: 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.

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
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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? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc.200451
K013024Selectiva GuidewireNeometrics, Inc.200115
K033758Hydrophilic GuidewireLake Region Mfg., Inc.20034
K080144Mandrel Guidewires or M-WiresLake Region Mfg., Inc.20083
K140485Mandrel GuidewireLake Region Medical20142
K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp.20042
K140482Mandrel GuidewireLake Region Medical20141
K140593Advance Salivary Balloon Catheter with Wire GuideCook, Inc.20140
K142397Predicate III GuidewireLake Region Medical20140
K081775The Medcomp .010 Vascular GuidewiresMedcomp20090

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, K040010 (Genesis Medical Interventional, Inc., 2004) has gone furthest, with 51 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 Lake Region Mfg., Inc.

42 FDA decisions under this applicant name. See the company

  • K092965Trailrunner GuidewiresLake Region Mfg., Inc. · 2010
  • K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc. · 2008
  • K081708Taxi Endoscopic GuidewireLake Region Mfg., Inc. · 2008
  • K080144Mandrel Guidewires or M-WiresLake Region Mfg., Inc. · 2008
  • K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008

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/K011084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011084: Mandrel Guidewire Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011084

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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