510(k) · Cleared
ClearedEnsite Array Multi-Electrode Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on May 3, 2012 as substantially equivalent to K983456 (Endocardial Solutions, Inc., 1999) after a 30-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 3, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983456 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983456 Ensite 3000 SystemEndocardial Solutions, Inc. · 1999
- This deviceK121006 Ensite Array Multi-Electrode Diagnostic CatheterSt Jude Medical · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983456 | Ensite 3000 System | Endocardial Solutions, Inc. | 1999 | — |
| 0 (this device) | K121006 | Ensite Array Multi-Electrode Diagnostic Catheter | St Jude Medical | 2012 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K983456 | Ensite 3000 SystemSummary page 1…Recording Catheter Classification: Class 11, 21 CFR 870.1220, Product Code DRF Predicate Device(s): EnSite Array Multi-Electrode Diagnostic Catheter (K983456) The EnSite Array Multi-electrode Diagnostic Catheter (EnSite Array Cathet… | 1999 |
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?
- Its one ancestor has no recall.
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. 2012, this device’s year, is highlighted.
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 Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, 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 as stated in the FDA summary.
https://510kreport.com/device/K121006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121006: Ensite Array Multi-Electrode Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121006
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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