# DEN210037: SoClean 3+ Bacterial Reduction Device

- Pathway: De Novo (Direct)
- Applicant: Soclean, Inc.
- Decided: Aug 12, 2024 after 1,062 days
- Product code: QXQ (Respiratory Accessory Microbial Reduction Device.)
- Device class: 2
- Regulation: 21 CFR 880.6993
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252471: Paptizer 360 (2026), 0 descendants of its own
- K243815: SoClean 3+ (2025), 0 descendants of its own

## Indications for use
The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established. The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.

Source page: https://510kreport.com/device/DEN210037
Methodology: https://510kreport.com/methodology