510(k) · Cleared
ClearedMEDILOGAR4, MEDILOGAR12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tom Medical Entwicklungs GmbH · DSH Recorder, Magnetic Tape, Medical
Cleared on Apr 6, 2007 as substantially equivalent to K970902 (Oxford Instruments Medical Systems, 1997) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1995. 14 later devices descend from it.
- Decided
- Apr 6, 2007
- Review
- 11 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943862 (1995). 4 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 1 generation backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- This deviceK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- Descendant · cites it directly · 12 of its ownK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
- Descendant · 3 generations on · 5 of its ownK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
- Descendant · 4 generations on · 3 of its ownK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
- Descendant · 2 generations on · 3 of its ownK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc. · 2009 · cites it directly12descendants
- K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010 · 2 generations on6descendants
- K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011 · 3 generations on5descendants
- K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020 · 4 generations on3descendants
- K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc. · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −1 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| 0 (this device) | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| +1 | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C | Vasomedical, Inc. | 2009 | — |
| +2 | K101022 | Pulmotrack 5050 Wholter, Model 5050 | Karmelsonix | 2010 | — |
| +3 | K110525 | Vitalograph Model 7100 - Vitalojak | Vitalograph (Ireland), Ltd. | 2011 | — |
| +4 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020 | — |
| +2 | K092785 | Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis… | Vasomedical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970902 | Medilog FD4Summary page 1…35 Portmanmoor Road, Cardiff, Wales CF24 5HN, UK Predicate devices: Medilog FD4 [51 0 (k) Number K970902] DXP1 000 [51 0 (k Number K99361 18 (marketed as Medilog FD5) 1 Concise desc… | 1997 |
| * | K993618 | DXP1000 Holter RecorderSummary page 5…dilog AR4 and Medilog AR1 2, subject of this 510(k), have been compared to the following predicate devices: Medilog FD4 1510 (k) Number K970902], DXP1000 [510 (k) Number K993618] (marketed as Medilog FD5). The significant differences to the Medilog FD4 are found as: * Infrared interface - Medilog AR4 and… | 1999 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083820 (Vasomedical, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K970902.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (268 words)
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)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070818 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070818: MEDILOGAR4, MEDILOGAR12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070818
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026