| K-number | K261074 |
| Device name | BIOMONITOR IV (471155) |
| Applicant | Biotronik, Inc. |
| Product code | MXD |
| Device class | Class II |
| Decision date | May 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
The BIOMONITOR IV is a small, implantable cardiac monitor that detects and records subcutaneous ECGs to identify arrhythmias including atrial fibrillation, bradycardia, tachycardia, pause, and sudden rate drop. It is indicated for adults at increased risk of cardiac arrhythmias or experiencing transient symptoms suggestive of arrhythmia, and can be manually triggered by patients during symptomatic episodes.
The device uses two subcutaneous electrodes to continuously monitor cardiac rhythm and record up to 96 minutes of ECG data. Signals are filtered in two ways: a 10-40 Hz passband for QRS detection to suppress artifacts, and a 0.5-40 Hz passband for waveform display to retain diagnostic morphology. The system includes an insertable monitor, a programmer for setup and data review, and optional integration with BIOTRONIK Home Monitoring® for remote data transmission.
Not stated in this summary.
The proposed BIOMONITOR IV is substantially equivalent to the predicate device BIOMONITOR IV (K230375, cleared May 19, 2023) based on comparison of indications for use, principle of operation, product labeling, intended use, technological characteristics, and safety characteristics. The firmware updates demonstrate consistent performance with established specifications and introduce no new issues of safety or effectiveness compared to the predicate device.
View the full FDA submission: accessdata.fda.gov