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# SoClean CPAP Disinfecting Device Authorized
- URL: https://www.fdaweb.com/soclean-cpap-disinfecting-device-authorized/
- Published: 2024-08-19T12:00:00.000Z
- Updated: 2026-09-14T14:38:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157599

CDRH has granted a de novo marketing authorization for SoClean’s 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunct to reduce bacterial populations on certain compatible home-use continuous positive airway pressure masks and ventilation hoses after cleaning. An agency classification (Class 2) [letter](https://www.accessdata.fda.gov/cdrh%5Fdocs/pdf21/DEN210037.pdf?ref=fdaweb.com) says the device has demonstrated an in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ for the following bacteria: *Staphylococcus aureus* (ATCC 6538), *Klebsiella aerogenes* (ATCC 13048), *Staphylococcus hemolyticus* (ATCC 29970), *Escherichia coli* (ATCC 11229), *Staphylococcus hominis* (ATCC 27844), *Klebsiella pneumoniae* (ATCC 4352), *Pseudomonas aeruginosa* (ATCC 15442), and *Streptococcus pyogenes* (ATCC 14289).