510(k) Report

510(k) · Cleared

Cleared

Snap-on Torquer

K862409510(k) TraditionalCleared Jul 11, 198616-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

Advanced Cardiovascular Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Jul 11, 1986 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided
Jul 11, 1986
Review
16 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

29 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2010: 3 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2022: 2 descendants cleared2011: 2 descendants cleared2012: 5 descendants cleared2020: 2 descendants cleared2016: 3 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK862409 Snap-on TorquerAdvanced Cardiovascular Systems, Inc. · 1986
  2. Descendant · cites it directly · 28 of its ownK032411 JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003
  3. Descendant · 2 generations on · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
  4. Descendant · 3 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
  5. Descendant · 4 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
  6. Descendant · 5 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12009: 12010: 32011: 22012: 52014: 22015: 12016: 32017: 22018: 12020: 22021: 12022: 22023: 2
2003high 5 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 29 · See all
  • K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003 · cites it directly28descendants
  • K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · 2 generations on22descendants
  • K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 3 generations on21descendants
  • K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 4 generations on18descendants
  • K111338Wildcat CatheterAvinger, Inc. · 2011 · 5 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862409Snap-on TorquerAdvanced Cardiovascular Systems, Inc.1986—
+1K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc.2003—
+2K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.2006—
+3K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.2009—
+4K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.2010—
+5K111338Wildcat CatheterAvinger, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200910
201030
201120
201250
201420
201510
201630
201720
201810
202020
202110
202220
202320
FIG. 1 — Lineage of K862409, 1986–2023Source: 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
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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? (29)

See all 29

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc.200328

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, K032411 (Js Vascular, Inc., 2003) has gone furthest, with 28 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. “K862409: Snap-on Torquer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862409

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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