SleepRes, a company that’s reimagining therapy for sleep breathing disorders, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Kricket PAP device.

Powered by the company’s Kairos Positive Airway Pressure (KPAP) tech, Kricket is intended to treat obstructive sleep apnea (OSA) in patients over 66 pounds. It’s meant to be used in home, hospital/institutional, and sleep center settings.

The company’s proprietary KPAP technology is engineered to dynamically adapt pressure delivery throughout the breathing cycle instead of maintaining a constant, fixed pressure like traditional CPAP devices. KPAP synchronizes therapy with natural respiration and airway dynamics, aiming to reduce unnecessary pressure—which can minimize discomfort, alleviate common side effects, and improve tolerance during sleep.

In addition to the KPAP algorithm, the device includes traditional CPAP and automatic PAP therapy modes.

“This milestone marks an important moment for the field of sleep medicine,” said David White, MD, Harvard Medical School, and chief medical officer of SleepRes. “Kricket opens the door to a new category of positive airway pressure therapy that prioritizes comfort, the patient’s ability to adapt, and real-world use, while still delivering the therapy patients need. That balance is critical if we want to meaningfully improve long-term outcomes for people living with obstructive sleep apnea.”

CPAP therapy has been the standard of care for decades, but long-term adherence remains low due to pressure and mask-related issues. KPAP technology was designed to address the discomfort associated with CPAP therapy with an innovative approach to air pressure delivery.

“Today completes a 4+ year pursuit to provide my own patients with technology designed to emulate natural breathing and address the discomfort and pressure intolerance common with traditional CPAP,” said William H. Noah, MD, founder of SleepRes and inventor of KPAP. “Today also begins a new era of PAP therapy and a new hope not only for my patients but patients across the U.S., especially those beginning PAP or those who have previously tried and failed.”

The company plans to launch Kricket in the first half of 2026. The company said it’s preparing to scale manufacturing, develop clinical partnerships, and provide education on KPAP before launch.

“FDA clearance of Kricket marks a pivotal moment for patient care in sleep medicine,” said John Lipman, CEO of SleepRes. “It validates the innovation behind our technology and moves us another step closer to our mission of improving outcomes for people living with sleep apnea.”