# K103643: Ascot Home Medical Monitoring System (HMMS)

- Pathway: 510(k) (Abbreviated)
- Applicant: Ascot Technologies, Inc.
- Decided: Oct 6, 2011 after 297 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K864318 (1987). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043529: Accu-Chek Advisor Insulin Guidance Software, Roche Diagnostics Corp. (2005) Summary page 1.
- K081318: Onetouch Zoom Diabetes Management Program, Lifescan, Inc. (2008) Summary page 1.
- K083331: Confidant, Model 2.6, Confidant, Inc. (2009) Summary page 1.
- K100427: Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway, Taidoc Technology Corporation (2010) Summary page 1.

## Indications for use
This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home. This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or qualified medical provider. The physician or qualified medical provider will review the patient information from a web interface and may make medication changes and transmit those changes back to the patient for display on the Home Medical Station(FIMS). This medical device receives blood pressure, heart rate and blood glucose readings from the supported FDA approved medical devices via USH or serial connection to the HMS. The HMS communicates with the server via standard wireless or wired communication protocols such as cellular data, and wired or wireless internet. HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-790IT and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink. This medical device is automation of the exiting process of reporting results to the physician over the phone. This medical device is not intended to provide real time monitoring. It is not intended for emergency calls or for transmission of any time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment. This medical device uses standard communication protocols and encryption to protect patient privacy.

Source page: https://510kreport.com/device/K103643
Methodology: https://510kreport.com/methodology