510(k) · Cleared
ClearedIQ Hydrophilic Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Aug 1, 2003 as substantially equivalent to K030617 (Boston Scientific Scimed, Inc., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913353 (1991). 21 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 3 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 2 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 1 generation backK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
- This deviceK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
- Descendant · cites it directly · 3 of its ownK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK081021 Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008
- Descendant · 3 generations on · 0 of its ownK193194 CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK052783 Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp · 2005
Most influential descendants
Showing 4 of 4 · See all- K040140IQ Guide WireBoston Scientific Corp · 2004 · cites it directly3descendants
- K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008 · 2 generations on1descendant
- K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019 · 3 generations on0descendants
- K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −3 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −2 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −1 | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | 4 |
| 0 (this device) | K032183 | IQ Hydrophilic Guide Wire | Boston Scientific Corp | 2003 | — |
| +1 | K040140 | IQ Guide Wire | Boston Scientific Corp | 2004 | 1 |
| +2 | K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corp | 2008 | — |
| +3 | K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | 2019 | — |
| +2 | K052783 | Modification to: IQ Guide Wire, Models 38950-XX. 38951-XX | Boston Scientific Corp | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K030617 | PT2 Guide Wire and Addwire Extension Wire | 2003 |
| * | K973945 | Luge Guide WireSummary page 1…I, 21 CFR Part 870.1330 Device Predicate Devices PT2TMGuide Wire KO30617 May 21,2003 LuaeTMGuide Wire K973945 Januarv 12. 1998 Device The lQTMHydrophilic Guide Wires with ICE@hydrophilic coating Description are… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040140 | IQ Guide Wire | 2004 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K040140 (Boston Scientific Corp, 2004) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K030617.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The IQ™ Hydrophilic Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032183: IQ Hydrophilic Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032183
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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