# K253562: medilogFD

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Aug 14, 2026 after 270 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: 3 generations back to K943862 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070818: MEDILOGAR4, MEDILOGAR12, Tom Medical Entwicklungs GmbH (2007) Summary page 5.

## Indications for use
The medilogFD is an ambulatory ECG recorder intended to be used by or following instruction and under the direct supervision of a licensed physician in healthcare facilities or home environment to acquire, digitize, transmit and store data of up to a 12 lead ECG for a measuring duration of an extended period of 24 hours or more, including time point of the p-wave, R-peaks, time point of the pacemaker pulse, and ECG amplitudes. The medilogFD is indicated for use in adults and children greater than 10 kg/22Ibs who may be suspected to have cardiac rhythm disturbances or are otherwise directed for Holter monitoring such as in clinical research. The medilogFD is not protected against the effects of defibrillation . It is not indicated for life sustaining, life supporting or monitoring purposes nor for the treatment or alleviation of disease.

Source page: https://510kreport.com/device/K253562
Methodology: https://510kreport.com/methodology