# K261074: Biomonitor IV (471155)

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: May 1, 2026 after 30 days
- Product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K864889 (1987). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230375: Biomonitor IV, Biotronik, Inc. (2023) Summary page 5.

## Indications for use
The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias: * Pause * Tachycardia * Sudden Rate Drop * Bradycardia * Atrial fibrillation The BIOMONITOR IV is indicated for use in: * Patients who experience transient symptoms that may suggest a cardiac arrhythmia * Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

Source page: https://510kreport.com/device/K261074
Methodology: https://510kreport.com/methodology