The U.S. Food and Drug Administration has granted REMSleep Holdings, Inc. expanded 510(k) clearance for its DeltaWave nasal pillow system, significantly broadening the device's indicated use beyond home-based CPAP therapy to include institutional settings and a wider range of patient populations. The approval, granted January 15, 2026, represents a direct response to feedback from healthcare providers during the company's Q4 2025 soft launch who reported that patients in different care settings could benefit from DeltaWave but were restricted by the original clearance language.
The original 510(k) clearance, granted in 2024, limited DeltaWave to home use with continuous positive airway pressure devices for obstructive sleep apnea treatment. The supplemental clearance expands the indicated use in two critical ways: DeltaWave is now cleared for use in hospitals, long-term care facilities, rehabilitation centers, sleep laboratories, and other institutional environments for single-patient use, and it covers use with all non-invasive positive airway devices. This opens DeltaWave to patients with central sleep apnea, complex sleep apnea, congestive heart failure, neuromuscular diseases, and COPD - conditions requiring more modalities and therapy than traditional CPAP.
The expanded clearance addresses three strategic opportunities that surfaced during REMSleep's market entry. Hospitals and long-term care facilities struggle to find the right fit and function for patients so they can transition to the next care setting. Sleep laboratories conduct overnight studies where patients are fitted with masks and pressure settings are calibrated, and lab technicians requested access to DeltaWave for patients struggling with traditional interfaces during diagnostic sessions. Patients with congestive heart failure, COPD, or neuromuscular diseases often require BiPAP or ventilation modalities and frequently experience mask fit challenges that can lead to therapy abandonment.
REMSleep submitted the supplemental 510(k) application in early December 2025 after consolidating feedback from early adoption partners. The feedback was consistent: the device was performing well clinically, but the narrow indicated use created barriers to broader adoption. The expanded clearance positions REMSleep to execute on all three channels outlined in the company's Q1 2026 strategy announced December 30. DME/HME providers can now position DeltaWave as a rescue mask for patients failing traditional interfaces across all pressure modalities, not just CPAP. Sleep laboratories and pulmonologists can introduce patients to DeltaWave during diagnostic titration, creating brand preference before patients enter the home care channel. Institutional sales teams can now approach hospital respiratory departments, long-term care facilities, and rehabilitation centers with a device cleared for their patient populations and care environments.
The expanded 510(k) clearance is publicly available in the FDA's 510(k) Premarket Notification database under device number K253939 at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. REMSleep will update marketing materials, sales training, and product labeling to reflect the expanded indicated use. The company is notifying existing partners and potential institutional customers about the expanded clearance as it prepares to serve medically fragile populations who have historically faced significant challenges with traditional mask interfaces.
