510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

SoClean, Inc.

Peterborough, NH, US

SoClean, Inc. appears in FDA device records in Peterborough, NH. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for SoClean, Inc. between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for SoClean, Inc., by decision year
YearClearances
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243815SoClean 3+QXQSubstantially Equivalent
DEN210037SoClean 3+ Bacterial Reduction DeviceQXQUnknown

Registered establishments

FDA registered establishments for SoClean, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30095344093009534409SoClean, Inc.1 Vose Farm Road, Peterborough, NH 03458 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0695-2024SoClean 2, REF SC1200, Supplemental Hose and Mask 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.Class IIOpen, Classified
Z-0694-2024SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance SystemNew 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.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets SoClean, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain