510(k) · Cleared
ClearedAcorys Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corify Care S.L · DQK Computer, Diagnostic, Programmable
Cleared on Apr 13, 2026 as substantially equivalent to K162440 (Cardioinsight Technologies, Inc., 2016) after a 131-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Apr 13, 2026
- Review
- 131 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K000248 (2000). 16 ancestors in all, the oldest K874441 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 5 generations between
- 3 generations backK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- 2 generations backK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- 1 generation backK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- This deviceK253861 Acorys Mapping SystemCorify Care S.L · 2026
Show all 9 generations
- Root · 9 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 8 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 7 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 6 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 5 generations backK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- 4 generations backK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- 3 generations backK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- 2 generations backK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- 1 generation backK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- This deviceK253861 Acorys Mapping SystemCorify Care S.L · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −8 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −7 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −6 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −5 | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | — |
| −4 | K113811 | V2.6 Software for the Labsystem Pro EP Recording System | C.R. Bard Inc., Bard Electrophysiology Division | 2012 | — |
| −3 | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | — |
| −2 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| −1 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
| 0 (this device) | K253861 | Acorys Mapping System | Corify Care S.L | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K162440 | CardioInsight Cardiac Mapping SystemSummary page 9…imary predicate device PRIMARY PREDICATE DEVICE Product Name Medtronic CardioInsight™ Cardiac Mapping System Manufacturer Medtronic, Inc. 510(k) Number K162440 Regulation Number 21 CFR 870.1425 Regulation Name Programmable Diagnostic Computer Regulatory Class Class II Product Code… | 2016 |
| † | K211546 | Vektor Computational ECG Mapping System (vMap) | 2021 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 2 other devices also cite its predicate K162440.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ACORYS MAPPING SYSTEM is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
The ACORYS MAPPING SYSTEM is indicated for patients with cardiac arrhythmia and/or cardiac electrical disorders.
The ACORYS MAPPING SYSTEM is indicated for use in adults.
The ACORYS MAPPING SYSTEM can be used in regular medical consultations or in Hospitals during cardiac electrophysiological interventions.
The ACORYS MAPPING SYSTEM is indicated for use in intact skin only.
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/K253861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253861: Acorys Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253861
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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