Created by respiratory therapists to help you save lives.
Before Airon Corporation was established in 1997, our founders began their careers in respiratory therapy.
Their experiences inspired Airon’s development of innovative life support products that help healthcare workers more effectively care for patients—even the most fragile—in a variety of clinical settings.
The inherent safety and long-term reliability of our pneumatic technology make Airon’s ventilators and CPAP systems truly unique in today’s competitive world of electronics.
In fact, Airon’s technology was licensed by GE Healthcare and manufactured by Ford for the historic “50,000 Ventilators in 100 Days” response to Covid-19 in 2020.
And, in 2024, Airon Corporation was acquired by Inspiration Healthcare, a respected global provider of medical technology. This expanded group will leverage Airon’s established, trusted brand and reputation for high quality products, and add Airon’s innovative and complementary products to Inspiration Healthcare’s strong product portfolio to serve customers across an even wider global reach.
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
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.
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 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
2008
Airon responds with their new MACS stand-alone CPAP system. MACS CPAP provides EMS with an easy-to-use, rugged, lightweight option.
2009
2010
Airon exhibits at Arab Health and gains rapid exposure in Middle East and Asian markets
2011
2012
2013
2016
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
2024
Inspiration Healthcare is a respected global provider of medical technology. This event is a major milestone for both companies. It will leverage Airon’s established, trusted brand and reputation for innovative, high quality products, further enhance Inspiration Healthcare’s strong product portfolio, and expand both companies’ global presence. More about the acquisition.
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
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