510(k) · Decided

Decided

Modification to Ensite 3000 System, Model EE3000

K012926510(k) SpecialDecided Sep 28, 200128-day reviewClass II21 CFR 870.1220

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

Endocardial Solutions, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array

Cleared on Sep 28, 2001 as substantially equivalent to K001437 (Endocardial Solutions, Inc., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 55 later devices descend from it.

Decided: Sep 28, 2001
Review: 28 days
Class: Class II
Product code: MTD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001437 (2000). 55 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
This deviceK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
Descendant · cites it directly · 54 of its ownK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
Descendant · 2 generations on · 52 of its ownK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
Descendant · 3 generations on · 51 of its ownK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
Descendant · 4 generations on · 47 of its ownK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
Descendant · 5 generations on · 45 of its ownK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2003high 7 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 55 · See all

K030129Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003 · cites it directly54descendants
K042493Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004 · 2 generations on52descendants
K060954Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006 · 3 generations on51descendants
K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc. · 2007 · 4 generations on47descendants
K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · 5 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001437	Ensite 3000 System, Model EE3000	Endocardial Solutions, Inc.	2000	—
0 (this device)	K012926	Modification to Ensite 3000 System, Model EE3000	Endocardial Solutions, Inc.	2001	—
+1	K030129	Modification to Ensite 3000 System, Model EE3000	Endocardial Solutions, Inc.	2003	—
+2	K042493	Ensite System, Model EE3000	Endocardial Solutions, Inc.	2004	—
+3	K060954	Modification to Ensite System, Model EE3000	St. Jude Medical, Inc.-Endocardial Solutions	2006	—
+4	K072202	Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference…	Biosense Webster, Inc.	2007	—
+5	K090017	Carto 3 EP Navigation System, V1.0 and Accessories	Biosense Webster, Inc.	2009	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2006	1	0
2007	3	0
2009	3	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2016	1	0
2017	2	0
2018	5	0
2019	2	0
2020	2	0
2021	2	0
2022	3	0
2023	5	0
2024	4	0
2025	7	0
2026	5	0

FIG. 1 — Lineage of K012926, 2000–2026Source: 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 MTD? 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 MTD device

#1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.4 · 7 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
*	K001437	Ensite 3000 System, Model EE3000 Summary page 1 …electrode recording probe (21CFR 870.1220) b) Programmable diagnostic computer (21 CFR 870.1425) Predicate Device: Endocardial Solutions EnSite 3000 System 510(k) No. K001437 Device Description: The EnSite 3000 System is a computerized storage and display system for use in electrophysiology studies of…	Endocardial Solutions, Inc.	2000	—

Also cleared against K001437: 2 other devices →

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K030129	Modification to Ensite 3000 System, Model EE3000	Endocardial Solutions, Inc.	2003	54

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?

Its one ancestor has no recall.
Of its descendants, K030129 (Endocardial Solutions, Inc., 2003) has gone furthest, with 54 descendants of its own.
2 other devices also cite its predicate K001437.

How does its category compare?

All MTD devices

MTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MTD

2in 2024

2007high 4 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MTD

66in 2023

2007high 169 (2020) · low 66 (2023)2026

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

Recalls per year · MTD

2in 2017

2007high 2 (2017) · low 0 (2007)2026

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

Adverse event reports per year · MTD

385in 2025

2007high 385 (2025) · low 1 (2007)2025

MAUDE reports naming product code MTD, 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	0	—	0	1
2008	0	—	0	3
2009	0	—	0	6
2010	0	—	0	19
2011	0	—	0	14
2012	2	—	0	17
2013	2	—	0	30
2014	2	—	0	28
2015	0	—	0	36
2016	1	—	0	35
2017	2	—	2	38
2018	1	—	0	49
2019	0	—	0	77
2020	4	169	0	87
2021	1	—	0	99
2022	2	—	0	145
2023	3	66	0	184
2024	2	—	0	378
2025	0	—	0	385
2026	2	—	0	—

What is it indicated for?

The Ensite® Multi-electrode Diagnostic Catheter used with the Ensite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012926 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012926: Modification to Ensite 3000 System, Model EE3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012926

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026