# K070818: MEDILOGAR4, MEDILOGAR12

- Pathway: 510(k) (Traditional)
- Applicant: Tom Medical Entwicklungs GmbH
- Decided: Apr 6, 2007 after 11 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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: 2 generations back to K943862 (1995). 4 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970902: Medilog FD4, Oxford Instruments Medical Systems (1997) Summary page 1.
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 5.

## Most influential descendants
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C (2009), 12 descendants of its own
- K101022: Pulmotrack 5050 Wholter, Model 5050 (2010), 6 descendants of its own
- K110525: Vitalograph Model 7100 - Vitalojak (2011), 5 descendants of its own
- K201077: Strados Remote Electronic Stethoscope Platform (RESP) (2020), 3 descendants of its own
- K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301 (2010), 3 descendants of its own

## Indications for use
The MedilogAR4 and MedilogAR12 Digital Holter Recorders are used to record a 3 channel ECG and to measure the time intervals between consecutive R peaks in the ECG. The system is designed for a measuring duration of more than 24h and is therefore worn by the patient throughout the whole day. The preparation for the recording (attaching electrodes, etc.) is undertaken by the technician or doctor. During the recording, the instrument is carried in a special protective pouch which can be attached to a belt. The instrument is not designed for emergency monitoring purposes (intensive medical monitor); the instrument is only designed to record the ECG and/or information derived from ECG. The recorder is not protected against the effects of defibrillation as outlined in EN60601-2-25. The instruments also record other information: HF component of the ECG, time point of the P-wave, time point of the T-wave, and time point of the pacemaker pulse. In addition the MedilogAR12 records the ECG amplitude. Such monitoring is most frequent used for the indications below: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes (no online ST measurement implemented in recorder) 4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability (no online calculation implemented in recorder) 8. Reporting of QT interval (no online QT interval measurement implemented in recorder)

Source page: https://510kreport.com/device/K070818
Methodology: https://510kreport.com/methodology