Paptizer 360

The Paptizer 360 is an over-the-counter home-use device that reduces bacterial populations on CPAP mask cushions using UV-C LED light. After cleaning a mask cushion per the manufacturer's instructions, users place it in the device for a 30-minute automated cycle to achieve an additional 2-log (99%) bacterial reduction. It is designed for single-patient use and must not replace standard cleaning procedures.

The Paptizer 360 uses UV-C LEDs (260–280 nm wavelength) to irradiate mask cushion surfaces, whereas the predicate SoClean 3+ uses ozone generation. Both are Class II devices with the same FDA product code (QXQ) and intended purpose. The Paptizer has a shorter 30-minute cycle time compared to SoClean's 90 minutes, and is tested only with ResMed AirFit F20 mask cushions, whereas SoClean 3+ is tested with multiple ResMed products.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 18562-2 (particulate matter), ISO 18562-3 (volatile organic compounds), ISO 18562-4 (leachables), IEC 62471 (UV safety), IEC 60601-1-2 (EMC), ANSI/AAMI ES60601-1:2005 and IEC 60601-1-11/1-6 (electrical safety), ASTM D4169-22 (packaging), and ISO 17510 (CPAP equipment compatibility).

The Paptizer 360 is substantially equivalent to the predicate SoClean 3+ because both are Class II respiratory accessory microbial reduction devices with identical regulatory classification and intended use as adjuncts to reduce bacteria on CPAP equipment after cleaning. Although the technologies differ (UV-C versus ozone), non-clinical testing demonstrates the Paptizer achieves equivalent safety and performance, with 2-log bacterial reduction across clinically relevant species and biocompatibility, UV containment, and functional durability comparable to the predicate.