# K062304: DLM112 Daylink Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Rtx Healthcare A/S
- Decided: Sep 29, 2006 after 52 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: 8 generations back to K864318 (1987). 25 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041816: RTX3320PSTN Wireless Telehealth Gateway, Rtx Healthcare A/S (2004) Summary page 1.
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002) Summary page 1.
- K042273: Modification to Health Buddy with Device Connectivity, Health Hero Network, Inc. (2004) Summary page 1.

## Most influential descendants
- K090801: Electronic House Call (2009), 3 descendants of its own
- K071953: RTX3370 (2007), 3 descendants of its own
- K090886: RTX 3371 (2009), 2 descendants of its own
- K102063: Health-E-Connect System (2011), 1 descendant of its own
- K103796: Telemedcare Health Monitor (2011), 1 descendant of its own

## Indications for use
The Daylink 112 Monitor ("DLM1 12") 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 DLM1 12 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 center 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 DLM1 12 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

Source page: https://510kreport.com/device/K062304
Methodology: https://510kreport.com/methodology