# K122272: Cardiomem

- Pathway: 510(k) (Special)
- Applicant: Getemed Medizin- Und Informationstechnik AG
- Decided: Mar 28, 2013 after 241 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942704 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063042: Cardiomem CM 3000-12BT, Getemed Medizin- Und Informationstechnik AG (2007) Summary page 2.
- K022540: Cardio ID+(RZ153+), Rozinn Electronics, Inc. (2002) Summary page 1.

## Indications for use
The CardioMem® Models CM 4000/CM 4000B are Holter recorders which are indicated for patients who may benefit from a long-term continuous electrocardiographic (EGG) 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.

Source page: https://510kreport.com/device/K122272
Methodology: https://510kreport.com/methodology