FRONT-LINE Field Sterilizer (FL135)

FDA 510(k) K243801 · Fort Defiance Industries, LLC

Substantially Equivalent

510(k) numberK243801

Submission

Device name
FRONT-LINE Field Sterilizer (FL135)
Applicant
Fort Defiance Industries, LLC
Loudon, TN, US
Received
December 11, 2024
Decision date
March 7, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLE – Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Specialty
General Hospital

Other 510(k)s with product code FLE

510(k)DeviceApplicantDecision
K261055AMSCO 700 Steam SterilizerFLE · Traditional STERIS Corporation06/24/2026SE
K260254Enbio PROFLE · Traditional Enbio Group AG02/26/2026SE
K252307Getinge GSS67N Series Steam SterilizerFLE · Traditional Maquet GmbH (A Getinge Group Company)01/22/2026SE
K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE · Traditional Lucas Lifecare12/30/2025SE
K250164Cassette Autoclave (ACA5)FLE · Traditional Guangzhou Ajax Medical Equipment Co., Ltd.08/14/2025SE
K243994Steam Sterilizer (2545D)FLE · Traditional Ningbo Ican Machines Co., Ltd.06/06/2025SE
K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional Midmark Corporation04/04/2024SE
K233504Lexa MINI (RIS-303, RIS-305)FLE · Traditional W&H Sterilization S.R.L.02/08/2024SE
K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated Primus Sterilizer Company, LLC12/19/2023SE
K232658T-Top 10 & T-Top T-Top 11FLE · Traditional Tuttnauer U.S.A Co, Ltd.11/27/2023SE

More from Tuttnauer U.S.A Co, Ltd.

510(k)DeviceDecision
K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries…FLE · Abbreviated 03/02/2022SE
K141009Fort Defiance Automated Steam SterilizerFLE · Traditional 12/16/2014SE

Questions and answers

When was FRONT-LINE Field Sterilizer (FL135) cleared by the FDA?

FRONT-LINE Field Sterilizer (FL135) (K243801) received a 510(k) decision of Substantially Equivalent on March 7, 2025, 86 days after the submission was received.

What is the product code of K243801?

The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.