510(k) · Cleared
ClearedHI Torque Connect Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical · DQX Wire, Guide, Catheter
Cleared on Nov 3, 2011 as substantially equivalent to K033742 (Boston Scientific Corp, 2004) and 2 other predicates after a 78-day review. Its family tree reaches back 8 generations to 1989. 1 later device descends from it.
- Decided
- Nov 3, 2011
- Review
- 78 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K890505 (1989). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 4 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 3 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 2 generations backK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- 1 generation backK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- This deviceK112381 HI Torque Connect GuidewireLake Region Medical · 2011
- Descendant · cites it directly · 0 of its ownK140536 HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI…Lake Region Medical · 2014
Most influential descendants
Showing 1 of 1 · See all- K140536HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T…Lake Region Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −4 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −3 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −2 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| 0 (this device) | K112381 | HI Torque Connect Guidewire | Lake Region Medical | 2011 | — |
| +1 | K140536 | HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque… | Lake Region Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033742 | Boston Scientific V-18 Control WireSummary page 1…vices Manufacturer 510k Date Boston Scientific, V-18 K033742 12 Jan 2004 Asahi, Treasure K061984 05Th Oct 2006… | 2004 |
| * | K061984 | TreasureSummary page 1…Boston Scientific, V-18 K033742 12 Jan 2004 Asahi, Treasure K061984 05Th Oct 2006 Asahi, Astato 30 K071721 13h July 2007… | 2006 |
| * | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Summary page 1…Asahi, Treasure K061984 05Th Oct 2006 Asahi, Astato 30 K071721 13h July 2007 Principle of The Hi-Torque Connect guidewire is operated manually by a manual process Oper… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140536 | HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T… | 2014 | 0 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K140536 (Lake Region Medical, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033742.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112381: HI Torque Connect Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112381
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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