# K043085: Modification to: Pneuton Ventilator

- Pathway: 510(k) (Special)
- Applicant: Airon Corporation
- Decided: Dec 20, 2004 after 42 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: 2 generations back to K862830 (1986). 4 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024344: Pneuton Ventilator, Airon Corporation (2003) Summary page 1.
- K030803: Parapac 200D Transport, Model V200D, Pneupac, Ltd. (2003) Summary page 1.

## Most influential descendants
- K080692: Macs Cpap System (2008), 7 descendants of its own
- K092085: Ispira Resuscitation Unit (2009), 4 descendants of its own
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own
- K110119: Pressure Manometer (2011), 1 descendant of its own
- K093862: Carevent Handheld Cpap System (2010), 1 descendant of its own

## Indications for use
The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support: * positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask) CMV and IMV modes of ventilation * with or without PEEP / CPAP with oxygen or a mixture of air and oxygen The ventilator is suitable for use in: Pre-hospital transport applications including accident scene, emergency rescue vehicles - Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments - Air transport via helicopter or fixed wing

Source page: https://510kreport.com/device/K043085
Methodology: https://510kreport.com/methodology