Cleared Abbreviated

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

K213457 · Fort Defiance Industries, LLC · General Hospital

Mar 2022

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K213457 is an FDA 510(k) clearance for the Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries 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 2, 2022, 126 days after receiving the submission on October 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K213457 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2021
Decision Date	March 02, 2022
Days to Decision	126 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF