# K252471: Paptizer 360

- Pathway: 510(k) (Traditional)
- Applicant: LiViliti Health Products Corporation
- Decided: Apr 29, 2026 after 266 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
Longest line of descent: 1 generation back to DEN210037 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210037: SoClean 3+ Bacterial Reduction Device, Soclean, Inc. (2024) Summary page 5.

## Indications for use
The Paptizer 360 device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask cushions after cleaning. An in vitro 2-log (99%) bacterial reduction by the Paptizer 360 has been demonstrated for the following bacteria: Staphylococcus epidermidis (ATCC#: 12228), Staphylococcus aureus (ATCC#: 6538), Klebsiella pneumoniae (ATCC#: 13883), and Pseudomonas aeruginosa (ATCC#: 15442/10145), Escherichia coli (ATCC#: 11229), and Streptococcus pyogenes (ATCC#: 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established. The Paptizer 360 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 manufacturers. The Paptizer 360 device has been tested for use with ResMed AirFit F20 (mask cushion only). The safe use of the Paptizer 360 device with any other respiratory devices or accessories, such as headgear, mask frame, and mask elbow, has not been established.

Source page: https://510kreport.com/device/K252471
Methodology: https://510kreport.com/methodology