510(k) · Cleared

Cleared

Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)

K042850510(k) TraditionalCleared Aug 9, 2006663-day reviewClass II21 CFR 870.1250

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

Stereotaxis, Inc. · DQY Catheter, Percutaneous

Cleared on Aug 9, 2006 as substantially equivalent to K021802 (Stereotaxis, Inc., 2003) after a 663-day review. Its family tree reaches back 2 generations to 1999.

Decided: Aug 9, 2006
Review: 663 days
Class: Class II
Product code: DQY
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 deviceK042850 Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)Stereotaxis, Inc. · 2006

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)	K042850	Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)	Stereotaxis, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K042850, 1999–2006Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K021802	Stereotaxis Catheter Advancer System Summary page 1 …predicate device. Conclusion The Stereotaxis Cardiodrive® is substantially equivalent to the Stereotaxis Catheter Advancer System (CAS) (021802) predicate device. Contact Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products Date…	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 7 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 DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)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 Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping 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 catheter through the coronary vasculature nor the coronary sinus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042850 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042850: Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042850

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