# K041816: RTX3320PSTN Wireless Telehealth Gateway

- Pathway: 510(k) (Traditional)
- Applicant: Rtx Healthcare A/S
- Decided: Jul 19, 2004 after 13 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: 5 generations back to K864318 (1987). 12 ancestors in all.
59 later devices descend from it; 5 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K050929: The Hermes System (2005), 45 descendants of its own
- K062215: Confidant 2.0 (2006), 35 descendants of its own
- K072698: Confidant 2.5 (2007), 34 descendants of its own
- K052343: E-San Bluetooth Cradle (2005), 25 descendants of its own
- K061328: Think Positive Diabetes Management System (T+Diabetes System) (2006), 24 descendants of its own

## Indications for use
The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers. The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. RTX3320 is a "black box" device - it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company. This device does not measure, interpret or make any decisions on the vital data that it conveys. Contraindications, precautions and warnings This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data. Clinical judgement and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention.

Source page: https://510kreport.com/device/K041816
Methodology: https://510kreport.com/methodology