# K153473: Braemar Telemetry Patch System

- Pathway: 510(k) (Special)
- Applicant: Braemar Manufacturing, LLC
- Decided: Jul 22, 2016 after 233 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
Longest line of descent: 7 generations back to K963725 (1997). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Cardionet, Inc. (2010) Summary page 5.

## Most influential descendants
- K250356: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (2025), 0 descendants of its own

## Indications for use
The device is designated as Rx only. Its indications for use are as follows: 1. Patients who have a demonstrated need for cardiac Monitoring. These may include but are not limited to patients who require Monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. 8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter 9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation). 10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.

Source page: https://510kreport.com/device/K153473
Methodology: https://510kreport.com/methodology