OxySure

FDA Orders Consumers to Halt Using OxySure Therapeutics' Emergency Oxygen System

Back in June 2015, OxySure Therapeutics recalled replacement cartridges for its OxySure Portable Emergency Oxygen System, Model 615. But the FDA determined the action was ineffective and put out a safety alert Tuesday calling for consumers, healthcare providers, businesses and schools to immediately stop using the device.

The company pulled the cartridges last summer because they did not deliver enough oxygen. FDA standards require them to deliver at least 6 liters per minute of oxygen for a minimum of 15 minutes. The agency deemed it a Class II recall, where use or exposure to the product "may cause temporary or medically reversible adverse health consequences."

Now, the FDA is citing insufficient oxygen flow, rebreathing of exhaled gases, burns, bruising and exposure to chemicals in its alert. Chemical reactions in the canisters could also lead to explosions, the agency said.

Concept and technology

OxySure technology creates medically pure oxygen from two dry, inert powders which OxySure Systems, Inc. and Ross developed. The powders used in OxySure are safe to store and they only create oxygen once they are brought together by a patented actuation system. This allows for oxygen to be created on demand. OxySure eliminates the need for high-pressure tanks and valves, the storage of oxygen, potential explosions or fire hazards, and there are no environmental hazards or maintenance requirements. It is also safe for transportation.

In early 2008, OxySure Systems, Inc. developed and commercialized its first product, the OxySure Model 615, based on the OxySure technology. Model 615 is a portable emergency oxygen device designed for use by a lay person in any medical emergency. It can be administered by anyone, similar to a fire extinguisher or an automated external defibrillator (AED). It is intended to bridge the gap between the onset of the emergency and the medical care provided when first responders or paramedics arrive. The standard of care (SOC) for paramedics and professional rescuers worldwide is to administer oxygen upon arrival at the scene. Model 615 provides immediate access to oxygen while waiting for the emergency response team.

The OxySure Model 615 consists of an outer housing, oxygen mask and a disposable cartridge. The outer housing and the cartridge are made of thermoplastic materials. The disposable cartridge contains the two dry, inert proprietary powders inside a chamber. The powders are dry and inert until activated when the dial is turned. The cartridges are disposable while the outer housing is reusable. The unit will provide medically pure (USP) oxygen at a flow rate of six (6) liters per minute for at least 15 minutes.

In December 2005, OxySure Systems, Inc. received United States Food and Drug Administration ("FDA") clearance for its Model 615 (510(K), Class II). The approval number for its FDA clearance is K052396 and Model 615 is cleared for over the counter sale without the need for a prescription.

The OxySure Model 615 is currently being used in schools, businesses, churches, homes, public facilities, corporate and government buildings around the world. It can be used during medical emergencies such as cardiac arrests, asthma attacks, allergy attacks, heat exhaustion, hypoxia, migraines, poisoning, overdose, or smoke inhalation.

In February 2013, OxySure Systems, Inc. expanded their product line to include six (6) brands of AEDs. The OxySure Model 615 is frequently placed next to AEDs as a companion product to be available for use – post-resuscitation – in cardiac arrest emergency.

Awards and recognition

In 2011, OxySure was recognized as one of the top public companies in Dallas-Fort Worth. The same year it was named in MedVentures Top 10.

OxySure was a recipient of the 2010 Texas Lone Star Award for Innovation in Respiratory Technology.

OxySure was a finalist at the 2010 IMPACT Awards.

The company was named on the 2008 World's Best Technologies List.

OxySure was a finalist at the 2008 Tech Titans Innovators Awards.