# K992478: Physiological Signal Transmitter and Receiver, Model 3810A

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard, Healthcare Solutions Group
- Decided: Oct 15, 1999 after 81 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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.
35 later devices descend from it; 1 cites it directly.
0 of 46 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
- K041674: The M3810A Philips Telemonitoring System with M3814A SPO2 Unit (2004), 34 descendants of its own
- K063612: Modification to Health Buddy Appliance (2006), 30 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 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 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/K992478
Methodology: https://510kreport.com/methodology