510(k) · Cleared
ClearedSonicaid Model MR-63 Ambulatory Ecg Recorder
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 Jun 7, 1995 after a 303-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 85 later devices descend from it.
- Decided
- Jun 7, 1995
- Review
- 303 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
85 later devices descend from it, 1 citing it directly.
- This deviceK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- Descendant · cites it directly · 84 of its ownK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- Descendant · 2 generations on · 68 of its ownK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- Descendant · 3 generations on · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
- Descendant · 4 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 5 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K970902Medilog FD4Oxford Instruments Medical Systems · 1997 · cites it directly84descendants
- K990727Syneflash & SyneviewEla Medical, Inc. · 1999 · 2 generations on68descendants
- K032466SpiderviewEla Medical, Inc. · 2003 · 3 generations on56descendants
- K042108Vista PlusNovacor · 2005 · 4 generations on46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 5 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| +1 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| +2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| +3 | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| +4 | K042108 | Vista Plus | Novacor | 2005 | — |
| +5 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (85)
See all 851 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970902 | Medilog FD4 | 1997 | 84 |
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?
- Of its descendants, K970902 (Oxford Instruments Medical Systems, 1997) has gone furthest, with 84 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 | — |
https://510kreport.com/device/K943862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943862: Sonicaid Model MR-63 Ambulatory Ecg Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943862
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026