510(k) · Cleared
ClearedCardiodrive Catheter Advancement System (Cas)
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 Aug 24, 2007 after a 135-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Aug 24, 2007
- Review
- 135 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK071029 Cardiodrive Catheter Advancement System (Cas)Stereotaxis, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK122659 Vdrive W/V-SonoStereotaxis, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK183027 Steerable catheter control systemStereotaxis, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK140804 Vdrive with V-Loop/ Vdrive DuoStereotaxis, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK133396 Vdrive with V-SonoStereotaxis, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation…Stereotaxis, Inc. · 2019 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122659Vdrive W/V-SonoStereotaxis, Inc. · 2013 · cites it directly4descendants
- K183027Steerable catheter control systemStereotaxis, Inc. · 2019 · cites it directly2descendants
- K140804Vdrive with V-Loop/ Vdrive DuoStereotaxis, Inc. · 2014 · 2 generations on2descendants
- K133396Vdrive with V-SonoStereotaxis, Inc. · 2014 · 2 generations on2descendants
- K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071029 | Cardiodrive Catheter Advancement System (Cas) | Stereotaxis, Inc. | 2007 | — |
| +1 | K122659 | Vdrive W/V-Sono | Stereotaxis, Inc. | 2013 | — |
| +1 | K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019 | — |
| +2 | K140804 | Vdrive with V-Loop/ Vdrive Duo | Stereotaxis, Inc. | 2014 | — |
| +2 | K133396 | Vdrive with V-Sono | Stereotaxis, Inc. | 2014 | — |
| +2 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and… | Stereotaxis, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | — | Cardiodrive® Catheter Advancement System Named without a submission number | |
| * | — | Stereotaxis Cardiodrive® Catheter Advancer System Named without a submission number | |
| * | — | Stereotaxis Catheter Advancement System (CAS) Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K122659 (Stereotaxis, Inc., 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071029: Cardiodrive Catheter Advancement System (Cas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071029
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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