# K241135: RESPOND (R) Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Corvent Medical, Inc.
- Decided: Nov 13, 2024 after 203 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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: 13 generations back to K953930 (1996). 174 ancestors in all.
No later device cites it as a predicate yet.
17 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181166: Trilogy Evo, Respironics, Inc. (2019) Summary page 5.

## Indications for use
The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg. The RESPOND(R) Ventilator is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.

Source page: https://510kreport.com/device/K241135
Methodology: https://510kreport.com/methodology