# K143503: BioMonitor

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Mar 19, 2015 after 99 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: 8 generations back to K864889 (1987). 56 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K132960: Biomonitor, Biotronik, Inc. (2014) Summary page 4.
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539), Medtronic, Inc. (2007) Summary page 4.
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator, St Jude Medical (2008) Summary page 4.

## Most influential descendants
- K152995: BioMonitor 2-AF, BioMonitor 2-S (2016), 8 descendants of its own
- 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

## Indications for use
The BioMonitor is indicated for: 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/K143503
Methodology: https://510kreport.com/methodology