# K130178: Inspiration Ventilator System 5I/7I

- Pathway: 510(k) (Traditional)
- Applicant: eVent Medical, Ltd.
- Decided: Oct 29, 2013 after 277 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 106 ancestors in all.
No later device cites it as a predicate yet.
9 of 107 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.
- K103803: Hamilton-G5, Hamilton Medical AG (2011) Summary page 1.

## Recalls of this device
- Oct 13, 2015 · Class I · Z-0230-2016: A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.

## Indications for use
The Inspiration 7i/5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressure-based or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1cm H2O. The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

Source page: https://510kreport.com/device/K130178
Methodology: https://510kreport.com/methodology