# K090886: RTX 3371

- Pathway: 510(k) (Traditional)
- Applicant: Tunstall Healthcare
- Decided: Apr 15, 2009 after 15 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: 10 generations back to K864318 (1987). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071953: RTX3370, Rtx Healthcare A/S (2007) Summary page 1.
- K072698: Confidant 2.5, Confidant, Inc. (2007) Summary page 1.

## Most influential descendants
- K103796: Telemedcare Health Monitor (2011), 1 descendant of its own
- K122333: Mobilecare Monitor (2012), 0 descendants of its own

## Indications for use
The RTX3371 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3371 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) using standard wireless technologies. The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.

Source page: https://510kreport.com/device/K090886
Methodology: https://510kreport.com/methodology