Cleared Special

FRONT-LINE Field Sterilizer (FL135)

K243801 · Fort Defiance Industries, LLC · General Hospital

Mar 2025

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K243801 is an FDA 510(k) clearance for the FRONT-LINE Field Sterilizer (FL135), a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Fort Defiance Industries, LLC (Loudon, US). The FDA issued a Cleared decision on March 7, 2025, 86 days after receiving the submission on December 11, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K243801 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2024
Decision Date	March 07, 2025
Days to Decision	86 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF