# K130516: Cardioday

- Pathway: 510(k) (Traditional)
- Applicant: Getemed Medizin- Und Informationstechnik AG
- Decided: Aug 23, 2013 after 177 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930564 (1995). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070280: Cardioday, Version 2.0, Getemed Medizin- Und Informationstechnik AG (2007) Summary page 1.

## Most influential descendants
- K162023: CardioDay V2.5 (2017), 1 descendant of its own
- K242583: AT-Patch (ATP-C130/ATP-C70) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K130516
Methodology: https://510kreport.com/methodology