# K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Nov 19, 2002 after 11 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: 4 generations back to K864318 (1987). 11 ancestors in all.
98 later devices descend from it; 10 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A, Hewlett-Packard Co. (1999) Summary page 1.

## Most influential descendants
- K031840: Carematix Wellness System (2003), 90 descendants of its own
- K040966: Modification to Carematix Wellness System (2004), 86 descendants of its own
- K041816: RTX3320PSTN Wireless Telehealth Gateway (2004), 59 descendants of its own
- K050929: The Hermes System (2005), 45 descendants of its own
- K042273: Modification to Health Buddy with Device Connectivity (2004), 45 descendants of its own

## Indications for use
The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinica judgment and experience are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K023749
Methodology: https://510kreport.com/methodology