Edan Instruments, Inc. · Class II · Cleared Feb 9, 2026
| K-number | K251591 |
| Device name | Holter ECG and ABP system (HolterABP) |
| Applicant | Edan Instruments, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Feb 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The Holter ECG and ABP system (HolterABP) is Windows-based software that acquires, analyzes, displays, edits, and generates reports of ambulatory ECG data, ambulatory blood pressure data, and combined Holter ECG/ABP data from compatible recorders. It performs automatic QRS detection and classification, arrhythmia detection, ST segment measurement, and creates summary tables and trends. The device is intended for retrospective analysis only in hospital and healthcare facilities by physicians or trained healthcare professionals.
The subject device shares the same ECG analysis capabilities as the primary predicate (SE-2003/SE-2012 Holter System), including identical review modes, rhythm analysis, ST segment measurement, pacemaker analysis, and HRV analysis. Key differences are: (1) addition of ABP data viewer displaying BP data tables, histograms, and pie charts; (2) Windows 11 operating platform versus Windows 10/11 in predicate; and (3) restriction of arrhythmia detection to patients over 12 years versus no age restriction in predicate. All ECG analysis functions remain substantially unchanged.
IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
The subject device is substantially equivalent because it shares the same intended use (ECG and blood pressure analysis for arrhythmia and ischemia evaluation) and technological characteristics with two predicate devices: the Holter System (K151787) for ECG analysis and the Ambulatory Blood Pressure Monitor (K210139) for ABP analysis. Bench testing and software verification/validation using public datasets (AHA, MIT-BIH, NST, ESC, QT) and proprietary data demonstrated performance metrics (sensitivity, specificity, accuracy) equivalent to clinically derived acceptance criteria. Differences in intended population age restrictions and operating platform do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov