510(k) · Cleared
Recalled · Class III · 2023Navik 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apn Health, LLC · DQK Computer, Diagnostic, Programmable
Cleared on Feb 23, 2016 as substantially equivalent to K120550 (Biosense Webster, Inc., 2012) after a 204-day review. Its family tree reaches back 11 generations to 2000. It has been recalled once.
- Decided
- Feb 23, 2016
- Review
- 204 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001437 (2000). 22 ancestors in all, the oldest K982415 (1998). No later device cites it as a predicate yet.
- Root · 11 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 7 generations between
- 3 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 2 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 1 generation backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- This deviceK152160 Navik 3DApn Health, LLC · 2016
Show all 11 generations
- Root · 11 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 10 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 9 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 8 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 7 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 6 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 5 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 4 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 3 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 2 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 1 generation backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- This deviceK152160 Navik 3DApn Health, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −10 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −9 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −8 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −7 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −6 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −5 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −4 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −3 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| −2 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 2 |
| −1 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| 0 (this device) | K152160 | Navik 3D | Apn Health, LLC | 2016 | — |
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 |
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 |
|---|---|---|---|
| * | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Summary page 4…Diagnostic Computer Regulatory Class: Class II Product Code: DQK 510(k) Number: K120550 510(k) Clearance Date: May 7, 2012 Description of the Device Navik 3D™ is a multi-compo… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2023 | Class III | Z-0556-2024 | Process control | IFU update |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120550.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152160: Navik 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152160
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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