The newly cleared PAP system with a proprietary algorithm will commercially launch in 2026.
Key takeaways:
- The FDA has granted 510(k) clearance to the Kricket PAP device from SleepRes for treating obstructive sleep apnea in patients weighing more than 66 lbs.
- Kricket uses Kairos Positive Airway Pressure technology, which adapts pressure delivery across the breathing cycle rather than holding a constant pressure.
- The device includes KPAP alongside conventional CPAP and auto-PAP modes.
- The technology builds on prior work by William H. Noah, whose earlier V-Com accessory showed improved short-term adherence in clinical testing.
- Company leadership frame the clearance as the start of a new PAP category focused on comfort and real-world use.
- SleepRes plans a commercial launch in the first half of 2026.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new PAP device that is designed to dynamically adapt pressure delivery throughout the breathing cycle, rather than maintaining a constant, fixed pressure like traditional CPAP devices.
Marketed as the Kricket PAP device by developer SleepRes Inc, it features proprietary Kairos Positive Airway Pressure (KPAP) technology for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. By synchronizing therapy with a patient’s natural respiration and airway dynamics, KPAP aims to reduce unnecessary pressure, which may minimize discomfort, alleviate common side effects, and improve tolerance during sleep.
The device includes the KPAP algorithm, as well as traditional CPAP and automatic PAP therapy modes. A published study of KPAP’s lower pressure found it to be just as effective as the continuous pressure of traditional CPAP while also finding most users report it as more comfortable.
“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,” says sleep physician William H. Noah, MD, founder of SleepRes and inventor of KPAP, in a release. “Today also begins a new era of PAP therapy and a new hope not only for my patients but patients across the US, especially those beginning PAP or those who have previously tried and failed.”
KPAP technology was designed to address the discomfort associated with CPAP therapy with an innovative approach to air pressure delivery that emulates human breathing for a more natural feel. Via SleepRes, Noah previously released a CPAP accessory named V-Com that reduces inspiratory pressure and flow to provide comfort with minimal to no reduction in expiratory pressure, which was shown to improve 90-day CPAP adherence in a trial.
“This milestone marks an important moment for the field of sleep medicine,” says David White, MD, chief medical officer of SleepRes, in a release. “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.”
SleepRes plans to commercially launch Kricket in the first half of 2026. The company is now preparing to scale manufacturing, developing clinical partnerships, and providing education on KPAP ahead of launch. Kricket is intended for home, hospital/institutional, and sleep center settings.
“FDA clearance of Kricket marks a pivotal moment for patient care in sleep medicine,” says John Lipman, CEO of SleepRes, in a release. “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.”
