# K024344: Pneuton Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Airon Corporation
- Decided: Jun 3, 2003 after 158 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: 1 generation back to K862830 (1986). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862830: Models 2R and 3R Pneupac Ventilator/Resuscitator, Pneupac, Ltd. (1986) Summary page 1.
- K896380: IC-2A Mri Adult/Pediatric Ventilator, Bio-Med Devices, Inc. (1990) Summary page 1.

## Most influential descendants
- K043085: Modification to: Pneuton Ventilator (2004), 9 descendants of its own
- 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

## 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 Ibs.) 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/K024344
Methodology: https://510kreport.com/methodology