Created by respiratory therapists to help you save lives.

Before Airon Corporation was established in 1997, our key leaders began their careers in respiratory therapy.

Their experiences inspired our development of innovative life support products that make it easier for healthcare workers to effectively care for even the most fragile patients in a variety of clinical settings.

Airon’s team brings together over 40 years’ proven experience in respiratory therapy, critical care medicine, emergency response, medical product design, research, and manufacturing.

The inherent safety and long-term reliability of our pneumatic technology make our ventilators and CPAP systems truly unique in today’s world of electronics.

In fact, Airon’s technology was licensed by GE Healthcare and manufactured by Ford for the 50,000 ventilators in 100 days response to Covid-19 in 2020.

All of our devices are proudly made in our Melbourne, Florida, USA headquarters to ensure our customers get the utmost quality they deserve.

Learn about our Quality

Airon Corporation is dedicated to the development, manufacture, and distribution of safe and effective medical devices designed for critical patient care. We continuously review our products, process, and customer comments to ensure our products and services meet the highest level of expectations. Our operations and products comply with all local, national, and international regulations.

Quality

Quality Management System
Airon’s quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. QMS is expressed as the organizational policies, procedures, processes and resources needed to implement quality management.

Quality Management System Certification
ISO 13485 Quality System Certification

Medical Device Single Audit Program (Mdsap)
Airon participated in the MDSAP regulatory audit of our medical device facility and quality management system; the MDSAP certificate indicates that Airon complies with the regulatory requirements for the markets defined in the certificate.

Airon Markets Include – United States Fda, Health Canada And European Union.
MDSAP Quality System Certification

Us Fda Good Manufacturing Practice (Gmp)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
View our Establishment Registration on the FDA website

Notified Body / Registrar / Certification Body
Airon Corporation maintains ISO 13485:2016 certification and is audited every year by:

Intertek Systems Certification
70 Codman Hill Rd
Boxborough, MA 01719
Telephone: +1 (978) 263-2662
www.intertek.com

Regulatory Compliance

International Regulatory Compliance Information

Under regulatory compliance, our goal is to take steps to comply with relevant laws, policies, and regulations for medical device manufacturing and marketing Airon products. All Airon products are designed, manufactured, and supported based upon sound quality procedures. Every device is CE marked as well as USA FDA cleared.

Product Certification and Approvals

USA – FDA Free Sale Certificate – Certificate to Foreign Government

Canada – Medical Device Licenses
pNeuton ventilator license | MACS license | patient circuit license

Europe – CE Marking certificates – Airon EC Certificate

Europe – Declarations of Conformity

USA – FDA 510(k) cleared
pNeuton A | pNeuton S | MACS | pNeuton mini

Global Regulatory Representative

Europe – Authorized Representative

Emergo Europe
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
Telephone: +31.70.345.8570

Clinical Applications
Our critical care ventilation + CPAP products help healthcare professionals worldwide care for even the most difficult patients in a variety of settings including: EMS, hospital ER and trauma, MRI, OR, ICU, and transport. Wherever your patients are located, our products provide the reliability and effectiveness you can depend on to help you deliver superior care.
hospital

Critical Care ventilation with CPAP for ER, MRI, OR, ICU, and transport

Our critical care ventilation + CPAP products are fully pneumatic, lightweight, portable, and easy-to-use.

Suitable for ER / trauma to special procedures and MRI, to the OR, ICU and intra or inter-facility transports via air or ground–you’ll have what you need for any patient, anywhere.

Intended for continuous ventilation of adult / pediatric patients 23 kg and greater who require the following general types of ventilatory support: 

  • Positive pressure ventilation delivered invasively, non-invasively or with CPAP
  • CMV and IMV ventilation modes
  • With / without PEEP/CPAP
  • With oxygen or a mix of air and oxygen

Both the pNeuton Model A and S are MRI compatible with no Gauss line restriction–the device can be placed next to the magnet.

The pNeuton Model A enhances patient safety with its integrated, all-pneumatic remote alarm for patient circuit disconnects and low gas supply from the bedside to the MRI observation room.

NEONATAL

Neonatal and pediatric life support ventilation for even the most fragile patients

Our critical care neonatal // infant / pediatric ventilators + CPAP products are fully pneumatic, small, lightweight, portable, and easy-to-use.

Suitable for ER, Delivery, MRI / Radiology, OR, Recovery, NICU and intra or inter-facility transports via air or ground–you’ll have what you need for any patient, anywhere.

Intended for continuous ventilation of neonatal / infant / child patients 400 grams to 20 kg.

who require the following general types of ventilatory support: 

  • Positive pressure ventilation delivered invasively, non-invasively or with CPAP
  • CMV and IMV ventilation modes
  • With / without PEEP/CPAP
  • With oxygen or a mix of air and oxygen

Both the pNeuton mini and the pNeuton NEO are:

  • Able to match the complexity of pressure-limited ventilation in standard infant ventilators
  • Easy-to-use with full range FiO2
  • Compatible with the Life Pulse High-Frequency Jet Ventilator from Bunnell Incorporated, providing conventional ventilation in tandem with the Life Pulse without interfering with high frequency ventilation or nuisance alarms
  • MRI compatible and have an integrated remote alarm to enhance patient safety
  • Built for in-hospital transport, as well as via ground, helicopter or fixed wing
mri

pNeuton ventilators overcome MRI concerns

Conventional medical devices and accessories were not designed for the harsh magnetic resonance (MR) environment that uses electromagnetic fields.

Airon’s line of pNeuton ventilators are built with our innovative pneumatic technology, and non-ferrous materials, so their performance does not interfere or cause artifact with the testing results.

Our pNeuton ventilators:

  • Are fully pneumatic – No batteries or electricity needed
  • Will not experience any electronic degradation over time that can malfunction as a result of interference from MR systems and cause service or repair costs
  • Can be placed right next to the magnet without needing to be permanently fixed to the floor or tethered to prevent missile-related accidents
  • Eliminate the need for Gauss line requirements
  • Are built without magnetic materials and have been test certified to minimize image artifact
  • Enhance patient safety with an integrated all-pneumatic alarm system with remote alarm for patient circuit disconnects and low gas supply from the bedside to the MRI observation room
ems

Advanced critical care CPAP for EMS with and without ventilation

When you need critical care support in the field, Airon’s MACS stand-alone CPAP System, and pNeuton Model S transport ventilator with built-in CPAP are the devices EMS professionals prefer.

MACS is a small, lightweight, pneumatic Continuous Positive Airway Pressure (CPAP) system designed for use on spontaneously breathing patients requiring up to 140 L/min oxygen at 65% or 100% concentrations.

The CPAP system provides expiratory positive pressure delivered non-invasively or invasively.

Suitable for use in pre-hospital and hospital settings, ER, OR, Recovery, accident scenes, and intra and inter-hospital transport.

The pNeuton Model S is intended for continuous ventilation of adult / pediatric patients 23 kg and greater who require the following general types of ventilatory support: 

  • Positive pressure ventilation delivered invasively, non-invasively or with CPAP
  • CMV and IMV ventilation modes
  • With / without PEEP/CPAP
  • With oxygen or a mix of air and oxygen

Suitable for use in pre-hospital transport applications including accident scenes, emergency rescue vehicles, hospital ICU transport applications including emergency, radiology, OR, post-anesthesia / recovery and MRI departments. Ground or air transport via helicopter or fixed wing.

The pNeuton Model S is MRI compatible with no Gauss line restriction–the device can be placed next to the magnet.

Both the MACS and the pNeuton Model S are built for ground or air transport, and have met the US Army Air Worthiness Certification requirements.

We are grateful for the opportunity to support you as you support patients in need. And to help you, and your patients, breathe easier. Every day.

How we got to today – Our steps of pride and progress

1997

Airon Corporation is established

The pNeuton family of ventilators takes form – designed for critically ill patients needing ventilatory support in EMS, ER, OR, ICU, Hospital and MRI. A prototype of their first ventilator was built. FDA documentation was created, and patent applications began.

2003

Airon launches its first product

Airon makes their debut appearance at the AARC in December 2003, and announces its first official product release. Patents awarded. FDA approval is granted for pNeuton. Airon begins product production.

2007

Airon enters European market
Canadian license and ISO–CE Mark granted to Airon, allowing Airon’s expansion into European markets. Airon exhibits at MEDICA for the first time in November 2007 to showcase its CE Mark

2008

Canada declares CPAP as standard equipment for EMS, and a BLS core protocol

Airon responds with their new MACS stand-alone CPAP system. MACS CPAP provides EMS with an easy-to-use, rugged, lightweight option.

2009

Expansion into the global market begins
Airon signs on with their first distributor for Asia and Indonesia

2010

International presence grows

Airon exhibits at Arab Health and gains rapid exposure in Middle East and Asian markets

2011

Airon – Companies to Watch in Florida
Airon Corporation receives the 2011 Florida Companies to Watch award in recognition of the company’s growth and contribution to the Melbourne and Florida economies. During the three years prior to the award, Airon averaged a 70% annual increase in revenue, increased employment, added two new products, become ISO certified, and expanded internationally.

2012

Airon’s pNeuton Mini wins EMS World 2012 Innovation Award.
Reviews post accolades such as “will change the way you deliver pre-hospital care,” and “a little workhorse that delivers big performance.”

2013

Florida Governor’s Business Ambassador recognizes Airon for international exportation

2016

Reinforcing a global commitment

Airon attends the European Conference on Pediatric & Neonatal Mechanical Ventilation in Montreux, Switzerland. Airon’s ongoing pledge is to provide high-quality, affordable critical care products to healthcare providers worldwide

2020

50,000 ventilators in 100 days: Airon is a game changer in the fight against COVID-19
Airon’s highly unique technology is licensed by GE Healthcare and manufactured by Ford to meet the national demand for ventilators. To help augment Ford’s production, Airon expands their Florida facility and doubles their production, all while continuing to meet their ongoing customer commitments.

Airon Corporation manufactures and markets innovative, reliable, effective, fully pneumatic oxygen-powered life support ventilation and CPAP products and accessories for healthcare workers worldwide. Our products support neonates, infants, pediatrics, children and adult patients in EMS, hospital ER and trauma, MRI, OR, ICU, and transport.

ADDRESS

751 North Drive,
Unit 6
Melbourne, Florida
32934, USA

Phone: 888-448-1238
(toll-free for North America only)

Phone: +1-321-821-9433
Fax: +1-321-821-9443

SOCIAL MEDIA

Copyright © 2023, Airon Corporation, All Rights Reserved
Web Development by: Sheep Don’t Bark