510(k) · Cleared
ClearedZymed Holter Scanner Model 2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Apr 25, 1994 after a 433-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 112 later devices descend from it.
- Decided
- Apr 25, 1994
- Review
- 433 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
112 later devices descend from it, 2 citing it directly.
- This deviceK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- Descendant · cites it directly · 108 of its ownK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- Descendant · 2 generations on · 89 of its ownK990170 Holter 2000Zymed Medical Instrumentation · 1999
- Descendant · 3 generations on · 85 of its ownK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 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 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996 · cites it directly108descendants
- K990170Holter 2000Zymed Medical Instrumentation · 1999 · 2 generations on89descendants
- K0109492010 Plus Holter for WindowsAgilent Technologies · 2001 · 3 generations on85descendants
- 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) | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| +1 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| +2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| +3 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 4 | 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 26.6 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (112)
See all 1122 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, K955015 (Zymed Medical Instrumentation, 1996) has gone furthest, with 108 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/K930806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930806: Zymed Holter Scanner Model 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930806
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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