510(k) · Cleared

Cleared

Cri Electronic Control System

K924125510(k) TraditionalCleared May 26, 1993282-day reviewClass II21 CFR 870.1290

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

Catheter Research C/O Burditt, Bowles & Radzius · DXX System, Catheter Control, Steerable

Cleared on May 26, 1993 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 40 later devices descend from it.

Decided: May 26, 1993
Review: 282 days
Class: Class II
Product code: DXX
Recalls: None
Predicates: 0

40 later devices descend from it, 1 citing it directly.

This deviceK924125 Cri Electronic Control SystemCatheter Research C/O Burditt, Bowles & Radzius · 1993
Descendant · cites it directly · 39 of its ownK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
Descendant · 2 generations on · 35 of its ownK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
Descendant · 3 generations on · 27 of its ownK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
Descendant · 4 generations on · 24 of its ownK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
Descendant · 5 generations on · 22 of its ownK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2002high 5 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 40 · See all

K013484Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System…Stereotaxis, Inc. · 2002 · cites it directly39descendants
K021555Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003 · 2 generations on35descendants
K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Hansen Medical, Inc. · 2007 · 3 generations on27descendants
K073225Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · 4 generations on24descendants
K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · 5 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K924125	Cri Electronic Control System	Catheter Research C/O Burditt, Bowles & Radzius	1993	—
+1	K013484	Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging…	Stereotaxis, Inc.	2002	—
+2	K021555	Stereotaxis Niobe Magnetic Navigation System	Stereotaxis, Inc.	2003	—
+3	K052480	Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical…	Hansen Medical, Inc.	2007	2
+4	K073225	Sensei Catheter Control System	Hansen Medical, Inc.	2008	1
+5	K090365	Hansen Medical Artisan S Control Catheter	Hansen Medical, Inc.	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2012	5	0
2013	1	0
2014	4	0
2015	4	0
2016	3	0
2018	3	0
2019	2	0
2020	2	0
2022	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K924125, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXX? 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 DXX device

#1 K251792 Stereotaxis GenesisX RMN with Navigant ™…score 13.9 · 3 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (40)

See all 40

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013484	Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System…	Stereotaxis, Inc.	2002	39

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, K013484 (Stereotaxis, Inc., 2002) has gone furthest, with 39 descendants of its own.

How does its category compare?

All DXX devices

DXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXX

2in 2025

2007high 4 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXX

76in 2018

2007high 156 (2015) · low 76 (2018)2026

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

Recalls per year · DXX

1in 2014

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXX

1in 2024

2007high 25 (2016) · low 0 (2008)2025

MAUDE reports naming product code DXX, 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	2	—	0	1
2008	1	—	0	0
2009	2	—	1	2
2010	1	—	0	0
2011	0	—	0	6
2012	4	155	0	2
2013	1	—	0	1
2014	4	104	1	14
2015	4	156	0	2
2016	2	—	0	25
2017	0	—	0	3
2018	3	76	0	9
2019	0	—	0	9
2020	1	—	0	4
2021	0	—	0	5
2022	1	—	0	1
2023	0	—	0	0
2024	0	—	0	1
2025	2	—	0	0
2026	1	—	0	—

https://510kreport.com/device/K924125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924125: Cri Electronic Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924125

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026