# K152995: BioMonitor 2-AF, BioMonitor 2-S

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 11, 2016 after 181 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: 9 generations back to K864889 (1987). 57 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143503: BioMonitor, Biotronik, Inc. (2015) Summary page 5.

## Most influential descendants
- K190548: BIOMONITOR III, Remote Assistant III (2019), 5 descendants of its own
- K200444: Biomonitor III, Biomonitor IIIm (2020), 4 descendants of its own
- K201865: Biomonitor III, Biomonitor IIIm (2020), 3 descendants of its own
- K221856: BIOMONITOR IIIm, BIOMONITOR III (2022), 2 descendants of its own
- K230375: Biomonitor IV (2023), 1 descendant of its own

## Indications for use
The BioMonitor 2 indicated to detect the following cardiac arrhythmias: - atrial fibrillation - bradycardia - sudden rate drop - high ventricular rate (HVR) - asystole The BioMonitor 2 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 is not intended for pediatric use

Source page: https://510kreport.com/device/K152995
Methodology: https://510kreport.com/methodology