510(k) · Cleared
Recalled · Class II · 2023Cardioserver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix · DQK Computer, Diagnostic, Programmable
Cleared on Nov 1, 2005 as substantially equivalent to K032038 (Quinton, Inc., 2003) after a 19-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945626 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
- 2 generations backK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
- 1 generation backK032038 Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
- This deviceK052883 CardioserverDatrix · 2005
- Descendant · cites it directly · 1 of its ownK103427 Mobileecg SystemMemtec Corp. · 2011
- Descendant · cites it directly · 0 of its ownK180432 AI-ECG PlatformShenzhen Carewell Electronics., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK123466 Healthview Ecg ManagerLumedx · 2012
Most influential descendants
Showing 4 of 4 · See all- K103427Mobileecg SystemMemtec Corp. · 2011 · cites it directly1descendant
- K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd. · 2018 · cites it directly0descendants
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 2 generations on0descendants
- K123466Healthview Ecg ManagerLumedx · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945626 | Quinton Model 710 Stress Electrocardiograph | Quinton, Inc. | 1995 | — |
| −2 | K964784 | Synergy Cardiology Information System (00431) | Quinton, Inc. | 1997 | — |
| −1 | K032038 | Pyramis Ecg Management System Model Numbers, 92600 and 92601 | Quinton, Inc. | 2003 | — |
| 0 (this device) | K052883 | Cardioserver | Datrix | 2005 | — |
| +1 | K103427 | Mobileecg System | Memtec Corp. | 2011 | — |
| +1 | K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | 2018 | — |
| +2 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
| +1 | K123466 | Healthview Ecg Manager | Lumedx | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K032038 | Pyramis Ecg Management System Model Numbers, 92600 and 92601Summary page 1…: The legally marketed device/s to which equivalence is being claimed is: Quinton Pyramis ECG Management System 3303 Monte Villa Parkway Bothell, WA 98021 K032038 Datrix CServer 510(k) Summary Appendix G 1iJ4… | 2003 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-2647-2023 | Under Investigation by firm | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103427 (Memtec Corp., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K032038.
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 CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs. The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients…
Read the full statement (110 words)
The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs.
The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to: review and edit specific patient ECG data including intervals such as QT measurements and algorithm generated preliminary interpretative statements. ECG records are all associated by patient ID and other demographic data. Secure access to the database is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052883: Cardioserver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052883
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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