510(k) · Cleared
ClearedPaptizer 360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LiViliti Health Products Corporation · QXQ Respiratory Accessory Microbial Reduction Device.
Cleared on Apr 29, 2026 as substantially equivalent to DEN210037 (Soclean, Inc., 2024) after a 266-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 29, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- QXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210037 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210037 SoClean 3+ Bacterial Reduction DeviceSoclean, Inc. · 2024
- This deviceK252471 Paptizer 360LiViliti Health Products Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210037 | SoClean 3+ Bacterial Reduction Device | Soclean, Inc. | 2024 | — |
| 0 (this device) | K252471 | Paptizer 360 | LiViliti Health Products Corporation | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QXQ device
- #1 K243815 SoClean 3+score 10.2 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210037 | SoClean 3+ Bacterial Reduction DeviceSummary page 5…obial Reduction Device Product Code: QXQ Predicate Device: SoClean 3+ Bacterial Reduction Device DEN210037 SoClean, Inc. Intended Use / Indications For Use: The Paptizer 360 device is intended to be u… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN210037.
How does its category compare?
All QXQ devicesQXQ Respiratory Accessory Microbial Reduction Device.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QXQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QXQ
Too few QXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QXQ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QXQ
1in 2025
MAUDE reports naming product code QXQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (162 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252471: Paptizer 360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252471
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026