510(k) · Cleared
ClearedEnsite Fusion Dynamic Registration Tool
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 Sep 11, 2008 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK082467 Ensite Fusion Dynamic Registration ToolSt Jude Medical · 2008
- Descendant · cites it directly · 28 of its ownK160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module…St Jude Medical · 2016
- Descendant · 2 generations on · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- Descendant · 3 generations on · 26 of its ownK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 4 generations on · 25 of its ownK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 5 generations on · 18 of its ownK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical · 2016 · cites it directly28descendants
- K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018 · 2 generations on27descendants
- K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 3 generations on26descendants
- K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 4 generations on25descendants
- K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical · 2020 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082467 | Ensite Fusion Dynamic Registration Tool | St Jude Medical | 2008 | — |
| +1 | K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | St Jude Medical | 2016 | — |
| +2 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| +3 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| +4 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| +5 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | 2016 | 28 |
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, K160187 (St Jude Medical, 2016) has gone furthest, with 28 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 | — |
https://510kreport.com/device/K082467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082467: Ensite Fusion Dynamic Registration Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082467
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026