510(k) · Cleared
ClearedModification to: Ensite System, Model, EE3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQK Computer, Diagnostic, Programmable
Cleared on May 1, 2007 as substantially equivalent to K060954 (St. Jude Medical, Inc.-Endocardial Solutions, 2006) after a 29-day review. Its family tree reaches back 5 generations to 2000. 7 later devices descend from it.
- Decided
- May 1, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001437 (2000). 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 4 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 3 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 2 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 1 generation backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- This deviceK070902 Modification to: Ensite System, Model, EE3000St Jude Medical · 2007
- Descendant · cites it directly · 4 of its ownK130750 Rhythmia Mapping SystemRhythmia Medical, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK162793 RHYTHMIA HDx Mapping SystemBoston Scientific Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK173837 RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation · 2018
- Descendant · 4 generations on · 1 of its ownK192438 Rhythmia HDxTM Mapping SystemBoston Scientific Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK241227 RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130750Rhythmia Mapping SystemRhythmia Medical, Inc. · 2013 · cites it directly4descendants
- K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation · 2017 · 2 generations on3descendants
- K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation · 2018 · 3 generations on2descendants
- K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation · 2019 · 4 generations on1descendant
- K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −4 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −3 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −2 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −1 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| 0 (this device) | K070902 | Modification to: Ensite System, Model, EE3000 | St Jude Medical | 2007 | — |
| +1 | K130750 | Rhythmia Mapping System | Rhythmia Medical, Inc. | 2013 | — |
| +2 | K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017 | — |
| +3 | K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | 2018 | — |
| +4 | K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | 2019 | — |
| +3 | K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 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 26.6 · 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 |
|---|---|---|---|
| * | K060954 | Modification to Ensite System, Model EE3000Summary page 1…1CFR 870.1220) b) Programmable diagnostic computer (21 CFR 870.1425) Predicate Device: EnSite System 5 10(k) No. K060954 Device Description: The EnSite System is a computerized storage and display system for use in electrophysiol… | 2006 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130750 (Rhythmia Medical, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K060954.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 EnSiteTM 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 NavXe 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/K070902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070902: Modification to: Ensite System, Model, EE3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070902
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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