What is FDA product code QXQ?

A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturers cleaning instructions.

General Hospital › MiscellaneousRespiratory Accessory Microbial Reduction Device.

SoClean

Name: SoClean
Brand: SoClean

SoClean 3+ Automated Supplemental Sleep Equipment Maintenance System

Registry build 21.09.26

2manufacturers in China registered for this device type

4catalogue numbers in this listing

2510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QXQ
Manufacturer	City	Province	Registered as	Device types
JDI Electronics Factory	Dongguan	Guangdong	Contract manufacturer	7
Zhongshan Sunclean Co., Ltd.	Zhongshan	Guangdong	Manufacturer	3

Record

Regulatory record for SoClean
Listed by	SoClean, Inc., United States
FDA product code	QXQ
Device type	Respiratory Accessory Microbial Reduction Device.
Device class	Class 2
Regulation	21 CFR 880.6993
Establishment	Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K243815
Record published	2026-06-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature -4 to 131 °F; Storage environment humidity 15 to 95 % RH; Handling environment temperature 50 to 90 °F; Handling environment humidity 15 to 65 % RH

Catalogue Numbers

Catalogue numbers for SoClean
Catalogue number	Size	Status
SC1450		In distribution
SC1450		In distribution
SC1450		In distribution
SC1450		In distribution

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243815	2025-10-10
DEN210037	2024-08-12

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-11-15	Class II	Labeling design	New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClea	40,075
2023-11-15	Class II	Labeling design	New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClea	2,339,352

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.