510(k) · Cleared
ClearedAcQMap High Resolution Imaging and Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Aug 27, 2021 as substantially equivalent to K201015 (Acutus Medical, Inc., 2020) after a 30-day review. Its family tree reaches back 11 generations to 1992. 4 later devices descend from it.
- Decided
- Aug 27, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921750 (1992). 17 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 7 generations between
- 3 generations backK191392 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019
- 2 generations backK193013 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- 1 generation backK201015 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- This deviceK212345 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK220784 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK222209 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK231091 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK230606 AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 10 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 9 generations backK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
- 8 generations backK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
- 7 generations backK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 6 generations backK130243 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 5 generations backK170948 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2017
- 4 generations backK190131 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019
- 3 generations backK191392 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019
- 2 generations backK193013 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- 1 generation backK201015 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- This deviceK212345 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022 · cites it directly3descendants
- K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022 · 2 generations on2descendants
- K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023 · 3 generations on0descendants
- K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −10 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −9 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 2 |
| −8 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 1 |
| −7 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −6 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −5 | K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017 | — |
| −4 | K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | — |
| −3 | K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | — |
| −2 | K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | — |
| −1 | K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | — |
| 0 (this device) | K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | — |
| +1 | K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022 | — |
| +2 | K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022 | — |
| +3 | K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023 | — |
| +3 | K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 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 26.7 · 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 |
|---|---|---|---|
| * | K201015 | AcQMap High Resolution Imaging and Mapping SystemSummary page 4…Manufacturer FDA 510(k) AcQMap High Resolution Imaging and Mapping System, Acutus Medical, Inc. K201015 Model 900100 K212345 510(k) SUMMARY Page 1 of 11… | 2020 |
| † | K170948 | AcQMap High Resolution Imaging and Mapping System | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220784 | AcQMap High Resolution Imaging and Mapping System | 2022 | 3 |
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 29 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K220784 (Acutus Medical, Inc., 2022) has gone furthest, with 3 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. 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 AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional…
Read the full statement (124 words)
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212345: AcQMap High Resolution Imaging and Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212345
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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