# K103214: M3810A Philips Telemonitoring System with Edevice BRIDGED130

- Pathway: 510(k) (Special)
- Applicant: Lifeline Systems, Inc.
- Decided: Dec 1, 2010 after 30 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). 15 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 19 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.
- K101242: Genesis DM Model: 6053000A1, Honeywell Hommed, LLC (2010) Summary page 2.

## Most influential descendants
- K141706: Ecare Coordinator (Ecc) (2014), 2 descendants of its own
- K171029: eCareCoordinator (2017), 1 descendant of its own
- K222398: Care Team Portal (2023), 0 descendants of its own

## Indications for use
The M38IOA Philips TeleMonitoring System with eDevice Bridgefll30 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 or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, isehemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post miyocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K103214
Methodology: https://510kreport.com/methodology