510(k) · Cleared
ClearedCardioday
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 Aug 23, 2013 as substantially equivalent to K070280 (Getemed Medizin- Und Informationstechnik AG, 2007) after a 177-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930564 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930564 Holter for WindowsNorth East Monitoring, Inc. · 1995
- 2 generations backK051471 CardiodayGetemed Medizin- Und Informationstechnik AG · 2005
- 1 generation backK070280 Cardioday, Version 2.0Getemed Medizin- Und Informationstechnik AG · 2007
- This deviceK130516 CardiodayGetemed Medizin- Und Informationstechnik AG · 2013
- Descendant · cites it directly · 1 of its ownK162023 CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017
- Descendant · 2 generations on · 0 of its ownK242583 AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930564 | Holter for Windows | North East Monitoring, Inc. | 1995 | — |
| −2 | K051471 | Cardioday | Getemed Medizin- Und Informationstechnik AG | 2005 | — |
| −1 | K070280 | Cardioday, Version 2.0 | Getemed Medizin- Und Informationstechnik AG | 2007 | — |
| 0 (this device) | K130516 | Cardioday | Getemed Medizin- Und Informationstechnik AG | 2013 | — |
| +1 | K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | 2017 | — |
| +2 | K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162023 | CardioDay V2.5 | 2017 | 1 |
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 18 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162023 (Getemed Medizin- Und Informationstechnik AG, 2017) has gone furthest, with 1 descendant 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. 2013, 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?
CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130516: Cardioday.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130516
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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