510(k) Report

510(k) · Cleared

Recalled · 2002

Magic Torque Guidewire

K933334510(k) TraditionalCleared Jan 26, 1994202-day reviewClass II21 CFR 870.1330Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · DQX Wire, Guide, Catheter

Cleared on Jan 26, 1994 after a 202-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled once.

Decided
Jan 26, 1994
Review
202 days
Class
Class II
Product code
DQX
Recalls
1
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2018: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK933334 Magic Torque GuidewireBoston Scientific Corp · 1994
  2. Descendant · cites it directly · 5 of its ownK053251 Techdevice GuidewireTechdevice Corporation · 2006
  3. Descendant · 2 generations on · 2 of its ownK110241 Endologix GuidewireTechdevice Corporation · 2011
  4. Descendant · 3 generations on · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
  5. Descendant · 4 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
  6. Descendant · cites it directly · 0 of its ownK182315 Magic Torque DLVR GuidewireBoston Scientific Corporation · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 22010: 12011: 12014: 12015: 12018: 12024: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K053251Techdevice GuidewireTechdevice Corporation · 2006 · cites it directly5descendants
  • K110241Endologix GuidewireTechdevice Corporation · 2011 · 2 generations on2descendants
  • K152177SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015 · 3 generations on1descendant
  • K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · 4 generations on0descendants
  • K182315Magic Torque DLVR GuidewireBoston Scientific Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933334Magic Torque GuidewireBoston Scientific Corp1994—
+1K053251Techdevice GuidewireTechdevice Corporation2006—
+2K110241Endologix GuidewireTechdevice Corporation2011—
+3K152177SonoStik IV Guide Wire IntroducerSonostik, LLC2015—
+4K243061SonoStik Guide Wire IntroducerSonostik, LLC2024—
+1K182315Magic Torque DLVR GuidewireBoston Scientific Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201010
201110
201410
201510
201810
202410
FIG. 1 — Lineage of K933334, 1994–2024Source: 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
  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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K053251Techdevice GuidewireTechdevice Corporation20065
K182315Magic Torque DLVR GuidewireBoston Scientific Corporation20180
K053028Techdevice GuidewireTechdevice Corporation20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 27, 2002Not classifiedZ-0666-03OtherThe 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053251 (Techdevice Corporation, 2006) has gone furthest, with 5 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)—
Cite this page

510(k) Report. “K933334: Magic Torque Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933334

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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