ButterflyBVM Earns FDA Clearance

The ButterflyBVM is now FDA Cleared

Compact Medical has announced a major milestone: the ButterflyBVM has received FDA clearance for use across the United States.

The ButterflyBVM is a single-use resuscitator designed to help clinicians and first responders provide safer emergency ventilation. Unlike traditional Bag Valve Masks (BVMs), it features adjustable controls for tidal volume and peak inspiratory pressure. These built-in safeguards in addition to rate control, reduce the risk of over-ventilation, a common problem linked to poor outcomes in critical patients.

The device is the first BVM to be cleared for use on all patient sizes in the pre-hospital market, and it is cleared for use on all patients except neonates in the hospital.

FDA clearance followed extensive testing that showed the Butterfly BVM performs safely and effectively compared to existing devices. Classified as a Class II emergency ventilator, it meets the rigorous standards required for U.S. clinical use.

For Compact Medical, this clearance is more than a regulatory step — it’s a chance to make lifesaving care more reliable. For healthcare workers, it promises a device that’s simpler, smarter, and safer for patients when every breath counts.

The ButterflyBVM is being rolled out across the United States over the next few months. Healthcare agencies who are ready to order the ButterflyBVM can get on the official waitlist here.