510(k) · Cleared
ClearedEnsite System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocardial Solutions, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Oct 30, 2003 as substantially equivalent to K030129 (Endocardial Solutions, Inc., 2003) after a 27-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 30, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001437 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 2 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 1 generation backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- This deviceK033211 Ensite SystemEndocardial Solutions, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −2 | 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 | — |
| 0 (this device) | K033211 | Ensite System | Endocardial Solutions, Inc. | 2003 | — |
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K030129 | Modification to Ensite 3000 System, Model EE3000 | 2003 |
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 3 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K030129.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The EnSite System is indicated for patients for whom electrophysiology studies are indicated.
When used with the Ensite Catheter, 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.
OR
When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033211 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033211: Ensite System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033211
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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