510(k) · Cleared
ClearedVX1+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volta Medical · DQK Computer, Diagnostic, Programmable
Cleared on Jan 21, 2023 as substantially equivalent to K201298 (Volta Medical, 2020) after a 60-day review. Its family tree reaches back 9 generations to 2000. 4 later devices descend from it.
- Decided
- Jan 21, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001437 (2000). 17 ancestors in all, the oldest K982415 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 5 generations between
- 3 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 2 generations backK093566 Carto XP EP Navigation System, Version 10Biosense Webster, Inc. · 2010
- 1 generation backK201298 VX1Volta Medical · 2020
- This deviceK223516 VX1+Volta Medical · 2023
- Descendant · cites it directly · 2 of its ownK232616 Volta AF-XplorerVolta Medical · 2023
- Descendant · 2 generations on · 1 of its ownK243812 Volta AF-XplorerVolta Medical · 2025
- Descendant · cites it directly · 0 of its ownK252429 Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251518 Volta AF-Xplorer IIVolta Medical · 2025
Show all 9 generations
- Root · 9 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 8 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 7 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 6 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 5 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 4 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 3 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 2 generations backK093566 Carto XP EP Navigation System, Version 10Biosense Webster, Inc. · 2010
- 1 generation backK201298 VX1Volta Medical · 2020
- This deviceK223516 VX1+Volta Medical · 2023
Most influential descendants
Showing 4 of 4 · See all- K232616Volta AF-XplorerVolta Medical · 2023 · cites it directly2descendants
- K243812Volta AF-XplorerVolta Medical · 2025 · 2 generations on1descendant
- K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc. · 2025 · cites it directly0descendants
- K251518Volta AF-Xplorer IIVolta Medical · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −8 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −7 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −6 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −5 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −4 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −3 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −2 | K093566 | Carto XP EP Navigation System, Version 10 | Biosense Webster, Inc. | 2010 | — |
| −1 | K201298 | VX1 | Volta Medical | 2020 | — |
| 0 (this device) | K223516 | VX1+ | Volta Medical | 2023 | — |
| +1 | K232616 | Volta AF-Xplorer | Volta Medical | 2023 | — |
| +2 | K243812 | Volta AF-Xplorer | Volta Medical | 2025 | — |
| +1 | K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025 | — |
| +3 | K251518 | Volta AF-Xplorer II | Volta Medical | 2025 | — |
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 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 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 26.7 · 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 |
|---|---|---|---|
| * | K201298 | VX1Summary page 4…stem Classification Name: Programmable Diagnostic Computer Regulatory Class: 21 C.F.R § 870.1425 Product Code: DQK Predicate Devices Volta Medical, VX1 (K201298) Device Description The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the… | 2020 |
What descends from it? (4)
2 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 23 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K232616 (Volta Medical, 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K201298.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
The clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223516: VX1+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223516
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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