510(k) · Cleared
ClearedZBPro Diagnostic (Version 2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zbeats, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Sep 11, 2026 as substantially equivalent to K243252 (Zbeats, Inc., 2025) after a 121-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Sep 11, 2026
- Review
- 121 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003621 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 6 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 5 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 4 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 3 generations backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- 2 generations backK212112 Cardiologs Holter PlatformCardiologs Technologies · 2021
- 1 generation backK243252 ZBPro DiagnosticZbeats, Inc. · 2025
- This deviceK261580 ZBPro Diagnostic (Version 2.0)Zbeats, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −6 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −5 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −4 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −3 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| −2 | K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021 | — |
| −1 | K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025 | — |
| 0 (this device) | K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | 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 MLO? 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 MLO device
- #1 K241890 Philips Holter Analysis Systemscore 9.9 · 4 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 |
|---|---|---|---|
| * | K243252 | ZBPro DiagnosticSummary page 6…evice(s) Predicate Type 510(k) Number Device Name Manufacturer Product Code Primary K243252 ZBPro Diagnostic (v1.0) ZBeats, Inc. DPS, DQK 5.7 Indications for Use ZBPr… | 2025 |
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 3.2 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population. The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead wearable ECG patch configurations that use wet gel…
Read the full statement (247 words)
ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population.
The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead wearable ECG patch configurations that use wet gel electrodes. The device analyzes Lead II, CMS (Ch 1), Modified-MUI (Ch 2+), or MLII (single lead) but does not perform multi-lead analysis.
ZBPro is not intended for use with paced signals or recordings taken from pediatric patients.
ZBPro Diagnostic v2.0 can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.
ZBPro Diagnostic v2.0 provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis.
ZBPro Diagnostic v2.0 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.
ZBPro Diagnostic 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 as stated in the FDA summary.
https://510kreport.com/device/K261580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261580: ZBPro Diagnostic (Version 2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261580
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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