# K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Dec 20, 1999 after 89 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: 3 generations back to K864318 (1987). 10 ancestors in all.
103 later devices descend from it; 4 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790130: Scale, Digital Chair, Acme Medical Scale Co. (1979) Summary page 1.
- K964408: Poseidon Cardiac Monitoring System (PCMS), Instromedix, Inc. (1997) Summary page 1.
- K952882: Personal Telemedicine System, American Telecare, Inc. (1996) Summary page 1.

## Most influential descendants
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) (2002), 98 descendants of its own
- 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

## Indications for use
The Model 3810A is indicated for patients at home, who are capable and willing self-administrate this device, upon 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. Clinical judgement and experience are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K993169
Methodology: https://510kreport.com/methodology