Arthur Lih, an entrepreneur turned inventor, has developed LifeVac, the only anti-choking device authorized by the U.S. Food and Drug Administration (FDA), after a lengthy review process lasting over two and a half years. The device, credited with more than 6,000 successful rescues in 30 countries, uses a plunger, valve, and mask system to safely clear airway obstructions.

The idea for LifeVac originated more than a decade ago when Lih, then operating a freight company, was deeply affected by a conversation with a friend who recounted a child’s death from choking at a hospital. With a daughter the same age as the victim, Lih set out to create a device that could prevent such tragedies. Working initially in his garage, he experimented with various designs despite having no formal medical background or experience in manufacturing, FDA regulations, or scaling production.

Lih faced significant challenges convincing others of the device’s efficacy, particularly without credentials in healthcare. However, early successes, including a demonstration on a CPR mannequin that simulated removing an airway blockage, gave him confidence in the concept. His persistence eventually led to the device’s initial market release, where the first confirmed life saved was reported by a U.K. colleague soon thereafter.

LifeVac was initially categorized as a Class II device by the FDA but lacked formal evidence-based approval. The emergence of counterfeit versions prompted regulators to require LifeVac’s manufacturer to undergo a de novo classification review—an exhaustive process reserved for novel products—demanding extensive documentation and rigorous testing. This review included assessments of packaging, instructions, mask fit, pressure standards, and human factors testing, such as observing untrained individuals use the device.

Following the submission of approximately 4,000 pages of documentation, LifeVac gained FDA clearance, establishing it as the only approved device of its type.

The device’s adoption has steadily expanded worldwide, leveraging Lih’s background in logistics to support markets in Canada, the United Kingdom, and beyond. Adoption increased slowly at first but has accelerated in recent years. For example, Texas has mandated LifeVac in schools, where more than 10,000 institutions now keep the device on hand. Costco stores in the U.S. also stock LifeVac units alongside defibrillators. According to Lih, the current rate of lives saved far exceeds totals from previous years combined.

Lih emphasizes the straightforward nature of LifeVac’s purpose: a readily available solution to a common and potentially fatal problem. For him, the effort is also personal and emblematic of the impact an individual can have. “You don’t have to be a medical professional to change the world,” he said. His journey from truck driver to FDA device inventor serves as a testament to perseverance and innovation driven by necessity.

Lih remains committed to increasing access to LifeVac, particularly in schools, aiming to further reduce preventable deaths from choking incidents.