510(k) · Cleared
ClearedStereotaxis Catheter Advancer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DQY Catheter, Percutaneous
Cleared on Apr 8, 2003 as substantially equivalent to K990271 (Endosonics Corp., 1999) and 1 other predicate after a 309-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 309 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990271 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990271 Endosonics Trak Back DeviceEndosonics Corp. · 1999
- This deviceK021802 Stereotaxis Catheter Advancer SystemStereotaxis, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK042850 Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)Stereotaxis, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK051374 Cardiodrive Catheter Advancement SystemStereotaxis, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990271 | Endosonics Trak Back Device | Endosonics Corp. | 1999 | — |
| 0 (this device) | K021802 | Stereotaxis Catheter Advancer System | Stereotaxis, Inc. | 2003 | — |
| +1 | K042850 | Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile) | Stereotaxis, Inc. | 2006 | — |
| +1 | K051374 | Cardiodrive Catheter Advancement System | Stereotaxis, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K990271 | Endosonics Trak Back DeviceSummary page 1…nt manner to the Jomed Trak Back predicate device. Conclusion The Stereotaxis CardiodriveTMis substantially equivalent to the Jomed Trak Back (K990271) and the IntraLuminal Therapeutics ILT Catheter (KO0 1992) predicate devices. Contact Gary M. Rauvo… | 1999 |
| * | K001992 | Ilt 0.014 Catheter, Model C114NL2 | 2000 |
What descends from it? (2)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K042850 (Stereotaxis, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Stereotaxis CardiodriveTM is intended for automatically advancing and retracting only the Stereotaxis TangentTM Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The CardiodriveTM is intended to advance the Stereotaxis TangentTM Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the TangentTM Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021802: Stereotaxis Catheter Advancer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021802
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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