510(k) · Cleared
ClearedPC Holter Scanning System Simplicity, Altair 8200, 8300, 8400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burdick, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jul 3, 1995 after a 207-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it.
- Decided
- Jul 3, 1995
- Review
- 207 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 2 citing it directly.
- This deviceK945985 PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400Burdick, Inc. · 1995
- 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 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400 | Burdick, Inc. | 1995 | — |
| +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 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 26.7 · 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? (72)
See all 722 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, K990727 (Ela Medical, Inc., 1999) has gone furthest, with 68 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/K945985 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945985: PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945985
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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