510(k) · Cleared
ClearedImpresario
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Mar Medical Systems, LLC · DQK Computer, Diagnostic, Programmable
Cleared on Nov 12, 1999 after a 17-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Nov 12, 1999
- Review
- 17 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK993620 ImpresarioDel Mar Medical Systems, LLC · 1999
- Descendant · cites it directly · 6 of its ownK110001 Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK110569 Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK201921 Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110001Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd. · 2011 · cites it directly6descendants
- K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011 · 2 generations on4descendants
- K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc. · 2012 · 2 generations on3descendants
- K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014 · 3 generations on1descendant
- K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993620 | Impresario | Del Mar Medical Systems, LLC | 1999 | — |
| +1 | K110001 | Spacelabs Pathfinder SL Holter Analyzer | Spacelabs Healthcare, Ltd. | 2011 | 1 |
| +2 | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor) | Inovise Medical, Inc. | 2011 | — |
| +2 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +3 | K131883 | Audicor Cpam with SDB (Accelerometer Based) | Inovise Medical, Inc. | 2014 | — |
| +2 | K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 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 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? (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 |
|---|---|---|---|
| * | — | Del Mar Avionics Model 263 Spectrascan® Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110001 | Spacelabs Pathfinder SL Holter Analyzer | 2011 | 6 |
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, K110001 (Spacelabs Healthcare, Ltd., 2011) has gone furthest, with 6 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 | — |
What is it indicated for?
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
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/K993620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993620: Impresario.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993620
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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