# K952882: Personal Telemedicine System

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Sep 9, 1996 after 444 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
No predicates in its family tree.
142 later devices descend from it; 3 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Digital Blood Pressure Monitor: named in the summary without a submission number
- (no number) TelePhonic Stethoscope: named in the summary without a submission number
- (no number) Image Management System and Corabi DX2000 Dynamic Module: named in the summary without a submission number

## Most influential descendants
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A (1999), 103 descendants of its own
- 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

## Indications for use
The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication. The PTS is typically used in home health care situations as an augment to home care nursing. In essence, the PTS allows a medical practitioner to make a "video-visit"™ to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.

Source page: https://510kreport.com/device/K952882
Methodology: https://510kreport.com/methodology