# K092026: Easycare TX, TX Link

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 2, 2009 after 88 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: 3 generations back to K961783 (1996). 3 ancestors in all.
2 later devices descend 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)
- K072615: Txcontrol, Resmed, Ltd. (2008) Summary page 1.
- K040944: Rescontrol II, Resmed, Ltd. (2004) Summary page 1.

## Most influential descendants
- K113780: Easycare TX System (Connexuns) (2012), 1 descendant of its own
- K241939: EasyCare Tx 2 (2024), 0 descendants of its own

## Indications for use
The EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link. EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel 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 continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG). The Tx Link is intended to be used in a clinical environment.

Source page: https://510kreport.com/device/K092026
Methodology: https://510kreport.com/methodology