510(k) · Cleared
ClearedmedilogFD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Aug 14, 2026 as substantially equivalent to K070818 (Tom Medical Entwicklungs GmbH, 2007) after a 270-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 14, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943862 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 2 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- 1 generation backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- This deviceK253562 medilogFDSchiller AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −2 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| −1 | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| 0 (this device) | K253562 | medilogFD | Schiller AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070818 | MEDILOGAR4, MEDILOGAR12Summary page 5…dicate Device Device Name medilogAR4/medilogAR12 Device Manuf. TOM MEDICAL ENTWICKLUNGS (Acquired by Schiller AG) 510(k) Number K070818 Device Class II Product code DSH Regulation Number 21 CFR 870.2800 SCHILLER AG – August 202… | 2007 |
| † | K161062 | NR Recorder | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K070818.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
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…
Read the full statement (139 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253562: medilogFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253562
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026