510(k) · Cleared
ClearedKinetix Guidewire, Plus Guidewire
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 8, 2008 as substantially equivalent to K040140 (Boston Scientific Corp, 2004) after a 120-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Aug 8, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913353 (1991). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 5 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 4 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 3 generations backK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
- 2 generations backK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
- 1 generation backK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
- This deviceK081021 Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008
- Descendant · cites it directly · 0 of its ownK193194 CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −5 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −4 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −3 | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | 4 |
| −2 | K032183 | IQ Hydrophilic Guide Wire | Boston Scientific Corp | 2003 | — |
| −1 | K040140 | IQ Guide Wire | Boston Scientific Corp | 2004 | 1 |
| 0 (this device) | K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corp | 2008 | — |
| +1 | K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | 2019 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K040140 | IQ Guide WireSummary page 1…Class 1I,21 CFR Part 870.1330 Device Predicate Device February 12, IQTm Guidewire K040140 2004 Device The KinetiXTm Guidewires are two 0.014" PTCA Description guidewires utilizing a micro-slot… | 2004 |
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 |
|---|---|---|---|
| K193194 | CrossTorq 14 Guidewire | 2019 | 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 17 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K193194 (Scientia Cardio Access, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040140.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
KinetixTM Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The KinetixTM Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081021: Kinetix Guidewire, Plus Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081021
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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