510(k) · Cleared
Recalled · 2004Endovascular 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 Nov 27, 2002 as substantially equivalent to K970244 (Scimed Life Systems, Inc., 1997) and 1 other predicate after a 211-day review. Its family tree reaches back 2 generations to 1994. 1 of the 23 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 27, 2002
- Review
- 211 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941895 (1994). 14 ancestors in all, the oldest K913353 (1991). 8 later devices descend from it, 2 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 1 generation backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- This deviceK021363 Endovascular Guide WireStereotaxis, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK052347 Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK060454 Titan GuidewireLake Region Mfg., Inc. · 2006
- Descendant · cites it directly · 1 of its ownK043457 Modification to Endovascular Guide WireStereotaxis, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK080637 Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc. · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080364 Findrwirz Guide Wire System2 generations on · 2008
Most influential descendants
Showing 5 of 8 · See all- K042854Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005 · cites it directly6descendants
- K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006 · 2 generations on2descendants
- K060454Titan GuidewireLake Region Mfg., Inc. · 2006 · 3 generations on1descendant
- K043457Modification to Endovascular Guide WireStereotaxis, Inc. · 2005 · cites it directly1descendant
- K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −1 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| 0 (this device) | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | — |
| +1 | K042854 | Stereotaxis Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| +2 | K052347 | Titan Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +3 | K060454 | Titan Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +1 | K043457 | Modification to Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| +2 | 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 |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K970244 | Scimed Choice Family of Ptca Guide WiresSummary page 2…the ACS BMW Guide Wire predicate devices. Conclusion The Stereotaxis Endovascular Guide Wire is substantially equivalent to the BSC Choice Guide Wire (K970244) and the ACS BMW Guide Wire (K97 18 15) predicate devices. Contact Gary M. Rauvola, Director, Regulatory Af… | 1997 |
| * | K971815 | Asc Balance Middleweight Guide WireSummary page 2…ion The Stereotaxis Endovascular Guide Wire is substantially equivalent to the BSC Choice Guide Wire (K970244) and the ACS BMW Guide Wire (K97 18 15) predicate devices. Contact Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products Date Novembe… | 1997 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2004 | Not classified | Z-0594-04 | Other | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Not classified | Z-0592-04 | Other | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Not classified | Z-0593-04 | Other | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Not classified | Z-0590-04 | Other | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Not classified | Z-0591-04 | Other | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Not classified | Z-0595-04 | Other | The magnet at the end of the guidewire could break off. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K042854 (Stereotaxis, Inc., 2005) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K970244.
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 Stereotaxis Endovascular Guide Wire is 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.
Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with the Stereotaxis Endovascular Guide Wire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021363: Endovascular 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/K021363
Report an extraction error
Are you the manufacturer?
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