# K260051: CorVision® (91-205-Z0014)

- Pathway: 510(k) (Traditional)
- Applicant: CorVent® Medical, Inc.
- Decided: May 12, 2026 after 124 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: 2 generations back to K011861 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161411: Care Cycle Connect Application, Respironics, Inc. (2017) Summary page 5.

## Indications for use
CorVision® is only compatible with and intended for use exclusively with the CorVent® RESPOND® Ventilator (K241135) by qualified, trained personnel under the direction of a licensed clinician. This application wirelessly interfaces with the RESPOND® Ventilator to receive data and provides a supplemental display of ventilator parameters, settings, measurements, status, waveforms, and event log information. The application operates in read-only mode and has no ventilator settings or alarm control functions. The RESPOND® Ventilator is intended for pediatrics through adult patients weighing at least 38 kg (84 lbs). CorVision® is intended for use in hospital and institutional environments, including intra-hospital transport, long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities (same as the RESPOND® Ventilator). CorVision® is intended to supplement and not replace any part of the current ventilator monitoring procedures.

Source page: https://510kreport.com/device/K260051
Methodology: https://510kreport.com/methodology