# K113743: Evolution 3E Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Event Medical, Inc.
- Decided: Dec 18, 2012 after 364 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: 8 generations back to K902859 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
2 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072590: Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and Infant LS Ventilator System, Event Medical, Inc. (2008) Summary page 1.

## Indications for use
The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues. This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 Ilb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician. The eVolution 3e ventilator system is a class Ilb medical device to-be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.

Source page: https://510kreport.com/device/K113743
Methodology: https://510kreport.com/methodology