510(k) · Cleared

Cleared

Cardiodrive Catheter Advancement System

K051374510(k) SpecialCleared Jun 23, 200528-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stereotaxis, Inc. · DQX Wire, Guide, Catheter

Cleared on Jun 23, 2005 as substantially equivalent to K021802 (Stereotaxis, Inc., 2003) after a 28-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jun 23, 2005
Review: 28 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K990271 (1999). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990271 Endosonics Trak Back DeviceEndosonics Corp. · 1999
1 generation backK021802 Stereotaxis Catheter Advancer SystemStereotaxis, Inc. · 2003
This deviceK051374 Cardiodrive Catheter Advancement SystemStereotaxis, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990271	Endosonics Trak Back Device	Endosonics Corp.	1999	—
−1	K021802	Stereotaxis Catheter Advancer System	Stereotaxis, Inc.	2003	—
0 (this device)	K051374	Cardiodrive Catheter Advancement System	Stereotaxis, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K051374, 1999–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K021802	Stereotaxis Catheter Advancer System Summary page 2 …modifications described herein. performance data Conclusion The modified Cardiodrive® is substantially equivalent to the Cardiodrive® (K021802) predicate device. The modifications described herein do not affect the intended use of the device or alter…	Stereotaxis, Inc.	2003	—

Also cleared against K021802: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K021802.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)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 the Stereotaxis Tangent® Electrophysiology Catheter of 7F shaft diameter and 8F tip. The Cardiodrive® is intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent® Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051374: Cardiodrive Catheter Advancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051374

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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