# K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Braemar, Inc.
- Decided: Jul 31, 2008 after 70 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092947: Telesentry, Model TS01 (2010), 3 descendants of its own
- K153477: EMMa Electronic Monitoring Management (2016), 0 descendants of its own
- K152973: Dyna-Vision Telemonitoring System (2016), 0 descendants of its own
- K142180: Telesense (2014), 0 descendants of its own
- K111160: Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets) (2011), 0 descendants of its own

## Indications for use
The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

Source page: https://510kreport.com/device/K081444
Methodology: https://510kreport.com/methodology