510(k) · Cleared
ClearedSoClean 3+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soclean, Inc. · QXQ Respiratory Accessory Microbial Reduction Device.
Cleared on Oct 10, 2025 as substantially equivalent to DEN210037 (Soclean, Inc., 2024) after a 303-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Oct 10, 2025
- Review
- 303 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 deviceK243815 SoClean 3+Soclean, Inc. · 2025
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) | K243815 | SoClean 3+ | Soclean, Inc. | 2025 | — |
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 K252471 Paptizer 360score 11.3 · 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…ual Name: Respiratory accessory microbial reduction device Classification: 21 CFR 880.6993 Regulatory Class: Class II Product Code: QXQ Predicate Device: SoClean 3+ (DEN210037) Device Description: SoClean 3+ is an ozone-generating device intended to reduce populations of bacteria on the… | 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. 2025, 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 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 (A TCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC…
Read the full statement (180 words)
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 (A TCC 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 AirFit P10 (mask), ResMed ClimateLine Air (tubing), and Slimline (tubing) for ResMed AirSense 10 CP AP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243815: SoClean 3+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243815
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026