510(k) · Cleared
ClearedCardiologs Holter Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiologs Technologies · DPS Electrocardiograph
Cleared on Nov 18, 2021 as substantially equivalent to K170568 (Cardiologs Technologies, 2017) after a 135-day review. Its family tree reaches back 5 generations to 2000. 7 later devices descend from it.
- Decided
- Nov 18, 2021
- Review
- 135 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003621 (2000). 7 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 4 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 3 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 2 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 1 generation backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- This deviceK212112 Cardiologs Holter PlatformCardiologs Technologies · 2021
- Descendant · cites it directly · 1 of its ownK243252 ZBPro DiagnosticZbeats, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK223013 AccurECG Analysis SystemAccurkardia, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261580 ZBPro Diagnostic (Version 2.0)Zbeats, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252978 ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252361 AccurECG Analysis System (v2.0)Accurkardia, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K243252ZBPro DiagnosticZbeats, Inc. · 2025 · cites it directly1descendant
- K223013AccurECG Analysis SystemAccurkardia, Inc. · 2023 · cites it directly1descendant
- K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc. · 2026 · 2 generations on0descendants
- K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC · 2026 · cites it directly0descendants
- K252361AccurECG Analysis System (v2.0)Accurkardia, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −4 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −3 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −2 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −1 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| 0 (this device) | K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021 | — |
| +1 | K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025 | — |
| +1 | K223013 | AccurECG Analysis System | Accurkardia, Inc. | 2023 | — |
| +2 | K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | 2026 | — |
| +1 | K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026 | — |
| +2 | K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 DPS? 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 DPS device
- #1 K254255 S-Patch CardioAIscore 16.0 · 14 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 |
|---|---|---|---|
| * | K170568 | CardioLogs ECG Analysis PlatformSummary page 5…er Product Code/ Regulation: DQK, DPS 21 CFR 870.1425 / 21 CFR 870.2340 Classification: Class II Predicate Device: Cardiologs ECG Analysis Platform (K170568) I. Subject Device Description Cardiologs Holter Platform is a software only medical device with the following com… | 2017 |
What descends from it? (7)
5 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K243252 (Zbeats, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K170568.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment…
Read the full statement (216 words)
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis.
The Cardiologs Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
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/K212112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212112: Cardiologs Holter Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212112
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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