510(k) · Cleared
ClearediMap 3D Mapping & Navigation System (iMap System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardionxt, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Aug 16, 2021 as substantially equivalent to K160210 (St Jude Medical, 2016) and 2 other predicates after a 479-day review. Its family tree reaches back 6 generations to 2010.
- Decided
- Aug 16, 2021
- Review
- 479 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K093942 (2010). 10 ancestors in all, the oldest K961924 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK093942 Ensite Velocity System V1.3St Jude Medical · 2010
- 5 generations backK101667 Ensite Velocity System Referred to Ensite Velocity System with…St Jude Medical · 2010
- 4 generations backK112688 Ensite Velocity System V.3.0St Jude Medical · 2011
- 3 generations backK130594 Ensite Velocity SystemSt Jude Medical · 2013
- 2 generations backK141050 Ensite Velocity SystemSt Jude Medical · 2014
- 1 generation backK160186 EnSite Velocity Surface Electrode KitSt Jude Medical · 2016
- This deviceK201094 iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K093942 | Ensite Velocity System V1.3 | St Jude Medical | 2010 | — |
| −5 | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional… | St Jude Medical | 2010 | — |
| −4 | K112688 | Ensite Velocity System V.3.0 | St Jude Medical | 2011 | — |
| −3 | K130594 | Ensite Velocity System | St Jude Medical | 2013 | — |
| −2 | K141050 | Ensite Velocity System | St Jude Medical | 2014 | — |
| −1 | K160186 | EnSite Velocity Surface Electrode Kit | St Jude Medical | 2016 | — |
| 0 (this device) | K201094 | iMap 3D Mapping & Navigation System (iMap System) | Cardionxt, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K160210 | EnSite Precision Cardiac Mapping System v2.0Summary page 4…ondary Predicate EnSite Precision™ Cardiac Mapping System Primary Abbot St. Jude K160210 EnSite™ Velocity Cardiac Mapping System with EnSite™ Secondary Abbot St. Jude K160186 Velocity Surface Electrode K… | 2016 |
| * | K160186 | EnSite Velocity Surface Electrode KitSummary page 4…rdiac Mapping System Primary Abbot St. Jude K160210 EnSite™ Velocity Cardiac Mapping System with EnSite™ Secondary Abbot St. Jude K160186 Velocity Surface Electrode Kit (Commonly known as the NavX System) IBI Inquiry Diagnostic Catheter (Secondary Predicate)… | 2016 |
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 4…K160186 Velocity Surface Electrode Kit (Commonly known as the NavX System) IBI Inquiry Diagnostic Catheter (Secondary Predicate) Secondary Abbot St. Jude K961924 Page 1 of 6… | 1997 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K160210.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.
The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
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/K201094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201094: iMap 3D Mapping & Navigation System (iMap System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201094
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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