510(k) · Decided
DecidedEnsite 3000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocardial Solutions, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Apr 21, 1999 after a 203-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 21, 1999
- Review
- 203 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983456 Ensite 3000 SystemEndocardial Solutions, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK121006 Ensite Array Multi-Electrode Diagnostic CatheterSt Jude Medical · 2012
Most influential descendants
Showing 1 of 1 · See all- K121006Ensite Array Multi-Electrode Diagnostic CatheterSt Jude Medical · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983456 | Ensite 3000 System | Endocardial Solutions, Inc. | 1999 | — |
| +1 | K121006 | Ensite Array Multi-Electrode Diagnostic Catheter | St Jude Medical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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
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 |
|---|---|---|---|
| * | — | EP Technologies, Inc. Asymmetric Curve Steerocath Named without a submission number | |
| * | — | Biosense CARTO System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121006 | Ensite Array Multi-Electrode Diagnostic Catheter | 2012 | 0 |
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, K121006 (St Jude Medical, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MTD devicesMTD 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 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 Electrophysioclogy Workstation is intended to be used in the right atrium of patients with complex arrhythmias 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/K983456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983456: Ensite 3000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983456
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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