Data / Medical devices / United States / SoClean, Inc.
SoClean, Inc.: FDA-registered device maker in Peterborough, NH, United States, 2 510(k) clearances
SoClean, Inc. is registered with the FDA (registration 3009534409) in Peterborough, NH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009534409
- Address
- 1 Vose Farm Road, Peterborough, NH, United States, 03458
- Owner or operator
- SoClean, Inc. (10039873)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- September 24, 2012
- Registered through
- 2026
- Brand names listed
- SoClean 3+ Bacterial Reduction Device, SoClean Family of Products (SC1200, SC1400)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Respiratory Accessory Microbial Reduction Device. | QXQ | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2025 | K243815 | SoClean 3+ | QXQ | Substantially Equivalent | Soclean, Inc. | accessdata.fda.gov |
| August 12, 2024 | DEN210037 | SoClean 3+ Bacterial Reduction Device | QXQ | Unknown | Soclean, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 15, 2023 | 93570 | Class II | Ongoing | SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System | 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 SoClean device. | accessdata.fda.gov |
Compare with other makers
- All makers of Respiratory Accessory Microbial Reduction Device.
- All makers of Disinfectant, Medical Devices
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.