510(k) · Cleared
ClearedEpiphany Cardio Server Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epiphany Healthcare, LLC · DQK Computer, Diagnostic, Programmable
Cleared on Jul 30, 2018 as substantially equivalent to K133534 (Mckesson Israel, Ltd., 2014) after a 31-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Jul 30, 2018
- Review
- 31 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K842308 (1984). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 7 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 6 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 5 generations backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- 3 generations backK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- 2 generations backK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- 1 generation backK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- This deviceK181720 Epiphany Cardio Server MobileEpiphany Healthcare, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −7 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −6 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −5 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| −3 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| −2 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| −1 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| 0 (this device) | K181720 | Epiphany Cardio Server Mobile | Epiphany Healthcare, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2012 | 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 26.6 · 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? (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 |
|---|---|---|---|
| * | K133534 | Mckesson Cardiology Ecg MobileSummary page 4…21 CFR 870.1425 Product code: DQK Device Class: Class II Primary Predicate Device: McKesson Cardiology ECG Mobile (K133534) Reference Predicate Device: Cardio Server ECG Management System (K052883) Intended Use… | 2014 |
| † | K052883 | Cardioserver | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K133534.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following: • View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or…
Read the full statement (179 words)
Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following:
• View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or historical patient information originally stored, analyzed or received by the Cardio Server ECG Management System.
• View the ECG lead traces using different display settings.
• Compare the results of current ECG tests with the patient’s previous ECG test results stored on the Cardio Server ECG Management System.
• Perform manual ECG-related measurements using the electronic caliper tool.
• Communicate information with the Cardio Server ECG Management System such as login credentials and user settings.
Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. Epiphany Cardio Server Mobile is not intended for real time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181720: Epiphany Cardio Server Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181720
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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