510(k) · Cleared
ClearedAffera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 8, 2024 as substantially equivalent to K213264 (Biosense Webster, Inc., 2021) after an 85-day review. Its family tree reaches back 17 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 8, 2024
- Review
- 85 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K001437 (2000). 28 ancestors in all, the oldest K982415 (1998). 5 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 13 generations between
- 3 generations backK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
- 2 generations backK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
- 1 generation backK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
- This deviceK233943 Affera Mapping System (AFR-00003); Location Reference Patch Kit…Medtronic, Inc. · 2024
- Descendant · cites it directly · 4 of its ownK241828 Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK243892 Affera Integrated Mapping SystemMedtronic, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262005 Affera Integrated Mapping SystemMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250747 Globe® Pulsed Field SystemKardium, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243435 Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 16 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 15 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 14 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 13 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 12 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 11 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 10 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 9 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 8 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 7 generations backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- 6 generations backK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
- 5 generations backK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- 4 generations backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- 3 generations backK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
- 2 generations backK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
- 1 generation backK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
- This deviceK233943 Affera Mapping System (AFR-00003); Location Reference Patch Kit…Medtronic, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024 · cites it directly4descendants
- K243892Affera Integrated Mapping SystemMedtronic, Inc. · 2025 · 2 generations on1descendant
- K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026 · 3 generations on0descendants
- K250747Globe® Pulsed Field SystemKardium, Inc. · 2025 · 2 generations on0descendants
- K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −16 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −15 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −14 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −13 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −12 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −11 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −10 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −9 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| −8 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 2 |
| −7 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| −6 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 2 |
| −5 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | — |
| −4 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | — |
| −3 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 1 |
| −2 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | — |
| −1 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | — |
| 0 (this device) | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007)… | Medtronic, Inc. | 2024 | — |
| +1 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024 | — |
| +2 | K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 | — |
| +3 | K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026 | — |
| +2 | K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 | — |
| +2 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K213264 | CARTO 3 EP Navigation System Version 7.2Summary page 5…ascular Product Code: DQK 510(k) Number K233943 Predicate Device: CARTO® 3 EP Navigation System Version 7.2 (K213264) Device Description: Affera Mapping System (AFR-00003): The Affera Mapping System (mapping syste… | 2021 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | 2024 | 4 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K241828 (Medtronic, Inc., 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K213264.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Affera Mapping System: The Affera mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Location Reference Patch Kit: Refer to the instructions for use accompanying the compatible navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233943: Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233943
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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