| K-number | K251770 |
| Device name | SleepRes PAP System |
| Applicant | Sleepres, Inc. |
| Product code | BZD |
| Device class | Class II |
| Decision date | Dec 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5905 |
The SleepRes PAP system is a positive airway pressure device indicated for treating obstructive sleep apnea in patients weighing over 30 kg (66 lbs). It delivers continuous or auto-titrating pressure via a heated breathing tube and is intended for home, hospital, institutional, and sleep center use.
The device uses a microprocessor-controlled blower with integrated humidification and heating system. It operates in CPAP, APAP (auto-titrating), and KPAP modes—algorithms that adjust airway pressure during breathing. The heated tubing is separately compared to a reference device. Pressure range is 4–20 cmH₂O with flow 10–60 lpm and includes Wi-Fi connectivity for remote data access.
ISO 5367:2023, IEC 60601-1:2005, IEC 60601-1-2:2020, IEC 60601-1-11:2015, ISO 80601-2-70:2020, ISO 80601-2-74:2021, ISO 10993 biocompatibility series, and ISO 18562 breathing gas pathway standards. Software verification and human factors validation per FDA guidance.
The SleepRes PAP system is substantially equivalent to the Philips DreamStation 2 (predicate K200480) because both use identical fundamental technology (microprocessor-controlled blower with integrated heater), deliver the same therapeutic pressure range, achieve comparable clinical outcomes in a 50-patient sleep study showing no significant difference in AHI, sleep quality, or sleep architecture, and meet the same applicable performance and safety standards.
View the full FDA submission: accessdata.fda.gov