# K051471: Cardioday

- Pathway: 510(k) (Traditional)
- Applicant: Getemed Medizin- Und Informationstechnik AG
- Decided: Jun 29, 2005 after 26 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: 1 generation back to K930564 (1995). 1 ancestor in all.
4 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)
- K930564: Holter for Windows, North East Monitoring, Inc. (1995) Summary page 1.

## Most influential descendants
- K070280: Cardioday, Version 2.0 (2007), 3 descendants of its own
- K130516: Cardioday (2013), 2 descendants of its own
- 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. WARNING: CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.

Source page: https://510kreport.com/device/K051471
Methodology: https://510kreport.com/methodology