# K161411: Care Cycle Connect Application

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Feb 17, 2017 after 273 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011861 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011861: Bernoulli Ventilator Management System, Cardiopulmonary Corp. (2001) Summary page 4.

## Most influential descendants
- K260051: CorVision® (91-205-Z0014) (2026), 0 descendants of its own

## Indications for use
The Care Cycle Connect software application is intended for use with Trilogy Series ventilators by both caregivers and clinicians. The application pairs with the Trilogy device via a Bluetooth connection. The application provides the caregiver remote patient monitoring, and alarm surveillance. Alarm surveillance consists of both an audible tone and a visible alert if an alarm condition exists. The application provides the clinician with the ability to view, collect and store patient ventilator usage data. Care Cycle Connect also provides educational information on ventilator use to both caregivers and clinicians. It*s intended to be used in the home, and hospital/ institutional settings. The Care Cycle connect application is intended to supplement and not replace any part of the current device monitoring procedures.

Source page: https://510kreport.com/device/K161411
Methodology: https://510kreport.com/methodology