# K071953: RTX3370

- Pathway: 510(k) (Special)
- Applicant: Rtx Healthcare A/S
- Decided: Aug 8, 2007 after 23 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: 9 generations back to K864318 (1987). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062304: DLM112 Daylink Monitor, Rtx Healthcare A/S (2006) Summary page 1.

## Most influential descendants
- K090886: RTX 3371 (2009), 2 descendants of its own
- K103796: Telemedcare Health Monitor (2011), 1 descendant of its own
- K122333: Mobilecare Monitor (2012), 0 descendants of its own

## Indications for use
The RTX3370 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 RTX3370 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) over a normal residential telephone line. The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

Source page: https://510kreport.com/device/K071953
Methodology: https://510kreport.com/methodology