# K113780: Easycare TX System (Connexuns)

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 20, 2012 after 120 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961783 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092026: Easycare TX, TX Link, Resmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- K241939: EasyCare Tx 2 (2024), 0 descendants of its own

## Indications for use
EasyCare Tx is intended to be used with ResMed compatible therapy devices via the Tx Link. EasyCare Tx provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely. EasyCare Tx is intended to be used in a clinical environment. The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed compatible therapy devices. The Tx Link relays real-time signals measured by the ResMed compatible therapy device to a polysomnograph (PSG). The Tx Link is intended to be used in a clinical environment.

Source page: https://510kreport.com/device/K113780
Methodology: https://510kreport.com/methodology