# K092947: Telesentry, Model TS01

- Pathway: 510(k) (Traditional)
- Applicant: Scottcare Corporation
- Decided: Feb 26, 2010 after 155 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081444 (2008). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System, Braemar, Inc. (2008) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Feb 25, 2016 · Class II · Z-1315-2016: The firm received a complaint of the battery exploding while recharging.
- Jan 19, 2012 · Not classified · Z-1400-2012: Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.

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

Source page: https://510kreport.com/device/K092947
Methodology: https://510kreport.com/methodology