510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243815Substantially Equivalent

SoClean 3+

SoClean, Inc., Peterborough NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243815 is the FDA 510(k) clearance record for SoClean 3+, a class II device, cleared for Soclean, Inc. on under FDA product code QXQ (Respiratory Accessory Microbial Reduction Device.). FDA's definition for product code QXQ reads: "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...". FDA records list 2 510(k) clearances for Soclean, Inc., from to . As of , FDA records show no recalls naming K243815.

Clearance record

Decision date
Received
(303 days to decision)
Product code
QXQ Respiratory Accessory Microbial Reduction Device.
Regulation
21 CFR 880.6993
Device class
Class II
Review panel
General Hospital
Applicant
Soclean, Inc. 1 Vose Farm Rd., Peterborough NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXQ

Trailing 12 months
1 clearance under product code QXQ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260