# K021112: Inspiration Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: eVent Medical, Ltd.
- Decided: Nov 22, 2002 after 231 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: 4 generations back to K902859 (1991). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960010: Servo Ventilator 300 Computer Interface, Siemens Elema AB (1996) Summary page 1.
- K984379: Nellcor Puritan Bennett, 760 Ventilator System, Puritan Bennett Corp. (1998) Summary page 1.

## Most influential descendants
- K030341: Modification to Inspiration Ventilator System (2004), 4 descendants of its own
- K051550: Inspiration Ventilator System (2005), 3 descendants of its own
- K072590: Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and Infant LS Ventilator System (2008), 2 descendants of its own
- K130178: Inspiration Ventilator System 5I/7I (2013), 0 descendants of its own
- K113743: Evolution 3E Ventilator (2012), 0 descendants of its own

## Indications for use
The Inspiration™ Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

Source page: https://510kreport.com/device/K021112
Methodology: https://510kreport.com/methodology