510(k) · Cleared
ClearedMedilog FD4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Instruments Medical Systems · DSH Recorder, Magnetic Tape, Medical
Cleared on May 5, 1997 as substantially equivalent to K943862 (Oxford Instruments Medical Systems, 1995) after a 55-day review. Its family tree reaches back 1 generation to 1995. 84 later devices descend from it.
- Decided
- May 5, 1997
- Review
- 55 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943862 (1995). 84 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- This deviceK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- Descendant · cites it directly · 68 of its ownK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- Descendant · 2 generations on · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
- Descendant · 3 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 4 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 4 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K990727Syneflash & SyneviewEla Medical, Inc. · 1999 · cites it directly68descendants
- K032466SpiderviewEla Medical, Inc. · 2003 · 2 generations on56descendants
- K042108Vista PlusNovacor · 2005 · 3 generations on46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 4 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| 0 (this device) | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| +1 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| +2 | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| +3 | K042108 | Vista Plus | Novacor | 2005 | — |
| +4 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +4 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 18.0 · 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? (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 |
|---|---|---|---|
| * | K943862 | Sonicaid Model MR-63 Ambulatory Ecg RecorderSummary page 2…997 Contact : Charles Holz Regulatory Affairs Manager Name of device : Medilog FD4 Name of predicate :Medilog MR63 Classification name : Monitor - Electrocardiograph K943862 Description The Medilog FD4 uses the same case, mechanics, electrodes and input circuitry as the Medilog MR63. Visually, it loo… | 1995 |
What descends from it? (84)
See all 842 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?
- Its one ancestor has no recall.
- Of its descendants, K990727 (Ela Medical, Inc., 1999) has gone furthest, with 68 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medilog FD4 Holter monitor is intended to be used in the diagnosis of various cardiac disorders by the recording of ECG in an ambulatory mode. These disorders principally include cardiac arrhythmia’s and myocardial ischeamia.
The ECG data is used by the physician as an aid in the diagnosis of the patients condition. In some circumstances the patient may be hospitalised as part of the medical evaluation and Holter monitoring may be performed in conjunction with other non-invasive or invasive procedures. In such cases there is no interaction between the FD4 and other equipment.
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/K970902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970902: Medilog FD4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970902
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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