510(k) · Cleared
ClearedModification to Endovascular Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DQX Wire, Guide, Catheter
Cleared on Feb 28, 2005 as substantially equivalent to K021363 (Stereotaxis, Inc., 2002) after a 75-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Feb 28, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941895 (1994). 15 ancestors in all, the oldest K913353 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 2 generations backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- 1 generation backK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- This deviceK043457 Modification to Endovascular Guide WireStereotaxis, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK080637 Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −2 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| −1 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| 0 (this device) | K043457 | Modification to Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| +1 | K080637 | Powerasset Radiofrequency Guidwire, Model Various | Stereotaxis, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K021363 | Endovascular Guide WireSummary page 2…ntial The AssertTM Guide Wire is a substantially equivalent modification of the equivalence Stereotaxis Endovascular Guide Wire originally cleared under K021363. The modifications described herein do not affect the intended use of the device or alt… | 2002 |
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 |
|---|---|---|---|
| K080637 | Powerasset Radiofrequency Guidwire, Model Various | 2008 | 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 11 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K080637 (Stereotaxis, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021363.
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?
Stereotaxis AssertTM Guide Wires are intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043457: Modification to Endovascular Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043457
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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