# K171514: BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Jun 29, 2017 after 36 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: 10 generations back to K864889 (1987). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152995: BioMonitor 2-AF, BioMonitor 2-S, Biotronik, Inc. (2016) Summary page 4.

## Indications for use
The BioMonitor 2 is indicated to detect the following cardiac arrhythmias: • Atrial fibrillation, • Bradycardia, • Sudden rate drop, • High ventricular rate (HVR), • Asystole. The BioMonitor 2 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/K171514
Methodology: https://510kreport.com/methodology