# K230375: Biomonitor IV

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: May 19, 2023 after 95 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: 14 generations back to K864889 (1987). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221856: BIOMONITOR IIIm, BIOMONITOR III, Biotronik, Inc. (2022) Summary page 4.

## Most influential descendants
- K261074: Biomonitor IV (471155) (2026), 0 descendants of its own

## Indications for use
The BIOMONITOR 1V is indicated to detect the following cardiac arrhythmias: * Atrial fibrillation * Bradycardia * Sudden rate drop * Tachycardia * Pause The BIOMONITOR 1V is indicated for use in: * Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias * Patients who experience transient symptoms that may suggest a cardiac arrhythmia The device has not been tested for and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K230375
Methodology: https://510kreport.com/methodology