510(k) · Cleared
ClearedMedilog Excel 2 - Holter Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Instruments · DQK Computer, Diagnostic, Programmable
Cleared on Sep 13, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 148 later devices descend from it.
- Decided
- Sep 13, 2000
- Review
- 27 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
148 later devices descend from it, 4 citing it directly.
- This deviceK002544 Medilog Excel 2 - Holter Management SystemOxford Instruments · 2000
- Descendant · cites it directly · 95 of its ownK021176 Compumedics Somte SystemCompumedics Limited · 2003
- Descendant · 2 generations on · 48 of its ownK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 4 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 148 · See all- K021176Compumedics Somte SystemCompumedics Limited · 2003 · cites it directly95descendants
- K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 2008 · 2 generations on48descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 3 generations on40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002544 | Medilog Excel 2 - Holter Management System | Oxford Instruments | 2000 | — |
| +1 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| +2 | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| +2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 16 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (148)
See all 1484 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?
- Of its descendants, K021176 (Compumedics Limited, 2003) has gone furthest, with 95 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
https://510kreport.com/device/K002544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002544: Medilog Excel 2 - Holter Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002544
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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