510(k) · Cleared
ClearedCardioDay V2.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getemed Medizin- Und Informationstechnik AG · DQK Computer, Diagnostic, Programmable
Cleared on Mar 24, 2017 as substantially equivalent to K130516 (Getemed Medizin- Und Informationstechnik AG, 2013) and 1 other predicate after a 245-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Mar 24, 2017
- Review
- 245 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930806 (1994). 15 ancestors in all, the oldest K922171 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 6 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 5 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 4 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 3 generations backK051026 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2005
- 2 generations backK093141 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
- 1 generation backK132437 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc. · 2013
- This deviceK162023 CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017
- Descendant · cites it directly · 0 of its ownK242583 AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −6 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −5 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −4 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −3 | K051026 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2005 | — |
| −2 | K093141 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2009 | — |
| −1 | K132437 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| 0 (this device) | K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | 2017 | — |
| +1 | K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K130516 | CardiodaySummary page 4…Information: Device Manufacturer 510(k) Number Primary Predicate Device: GETEMED Medizin- und K130516 CardioDay® version 2.4 Informationstechnik AG Secondary Predicate Device: GE Medical Systems… | 2013 |
| * | K132437 | Mars Holter Analysis WorkstationSummary page 4…EMED Medizin- und K130516 CardioDay® version 2.4 Informationstechnik AG Secondary Predicate Device: GE Medical Systems K132437 MARS Holter Analysis Information Technologies Workstation 2 Reason for Submission Premarket no… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242583 | AT-Patch (ATP-C130/ATP-C70) | 2025 | 0 |
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 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K242583 (Atsens Co., Ltd., 2025) has gone furthest, with 0 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. 2017, 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 CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained…
Read the full statement (183 words)
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data.
The CardioDay V2.5 system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
Patient population includes both adult and pediatric human patients.
CardioDay V2.5 provides the user arrhythmia study and Holter analysis capabilities.
Data acquired may be used for the following indications:
* Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances,
« Evaluation of symptoms that may be due to myocardial ischemia,
» Detection of ECG events that alter prognosis in certain forms of heart disease,
* Detection and analysis of pacemaker function and failure,
* Determination of cardiac response to lifestyle,
* Evaluation of therapeutic interventions,
» Investigations in epidemiology and clinical trials.
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/K162023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162023: CardioDay V2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162023
Report an extraction error
Are you the manufacturer?
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