510(k) · Cleared
ClearedScioCardio ECG Analysis Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergen Technology Labs, LLC · DQK Computer, Diagnostic, Programmable
Cleared on Jul 9, 2026 as substantially equivalent to K212112 (Cardiologs Technologies, 2021) after a 295-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 9, 2026
- Review
- 295 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003621 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 5 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 4 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 3 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 2 generations backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- 1 generation backK212112 Cardiologs Holter PlatformCardiologs Technologies · 2021
- This deviceK252978 ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −5 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −4 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −3 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −2 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| −1 | K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021 | — |
| 0 (this device) | K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026 | — |
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 |
|---|---|---|---|
| * | K212112 | Cardiologs Holter PlatformSummary page 6…1 4. PREDICATE INFORMATION [807.92(A)(3)] Predicate(s) CardioLogs Holter Platform, (K212112) 5. DEVICE DESCRIPTION [807.92(A)(4)] The ScioCardio ECG Analysis Platform is made up of: • A web interface which provid… | 2021 |
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 26 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K212112.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The ScioCardio ECG Analysis Platform is intended for use by healthcare professionals or trained personnel in healthcare facilities for the assessment of cardiac rhythms and arrhythmias using ECG data in adults aged 22 years and older. The ScioCardio ECG Analysis Platform supports analyzing ECG data recorded from the ScioCardio ECG transmitter (K171019). The ScioCardio ECG Analysis platform provides ECG signal processing and analysis including QRS complex…
Read the full statement (145 words)
The ScioCardio ECG Analysis Platform is intended for use by healthcare professionals or trained personnel in healthcare facilities for the assessment of cardiac rhythms and arrhythmias using ECG data in adults aged 22 years and older.
The ScioCardio ECG Analysis Platform supports analyzing ECG data recorded from the ScioCardio ECG transmitter (K171019).
The ScioCardio ECG Analysis platform provides ECG signal processing and analysis including QRS complex detection, beat classification, and rhythm analysis. The reports include beat-by-beat analysis, heart rate measurement, and rhythm analysis.
The ScioCardio ECG Analysis Platform is not intended for use in life-supporting or sustaining systems, or for real-time ECG monitoring or alarm functions.
Interpretation results provided by the ScioCardio are not intended to be the sole means of diagnosis and are offered as an advisory aid to be used alongside clinician review, ECG patterns, patient history, clinical indications, and other diagnostic data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252978: ScioCardio ECG Analysis Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252978
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026