# K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Airon Corporation
- Decided: Oct 11, 2012 after 156 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: 3 generations back to K862830 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043085: Modification to: Pneuton Ventilator, Airon Corporation (2004) Summary page 1.
- K043495: Babypac, Smiths Medical International Ltd., Luton (2005) Summary page 1.
- K993167: Millennium Infant Ventilator, Sechrist Industries, Inc. (1999) Summary page 3.
- K110471: Babi Plus Infant Nasal Cannula System, A Plus Medical (2011) Summary page 6.

## Indications for use
The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support: * Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs) * CMV and IMV mode of ventilation with or without PEEP / CPAP * Provide oxygen or a mixture of medical air and oxygen Patient population: Neonates, infants, and children, from 400 g to.25 kg in weight Environments of Use * Inter and intra-hospital patient transport * Air & ground transport - Pressurized and non-pressurized aircraft (to 15,000 ft) * Intensive care units (short term use only - associated with patient transport) * Emergency Departments * Radiology suites including MRI (MR Conditional 3T) * Operating rooms (short term use only - associated with patient transport)

Source page: https://510kreport.com/device/K121379
Methodology: https://510kreport.com/methodology