510(k) K243801

FRONT-LINE Field Sterilizer (FL135) by Fort Defiance Industries, LLC — Product Code FLE

K243801 is an FDA 510(k) premarket notification submitted by Fort Defiance Industries, LLC for the device "FRONT-LINE Field Sterilizer (FL135)". The FDA issued a decision of Substantially Equivalent on March 7, 2025. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Fort Defiance Industries, LLC has at least 2 other 510(k) clearances on record.