Fort Defiance Automated Steam Sterilizer

FDA 510(k) K141009 · Fort Defiance Industries, Inc.

Substantially Equivalent

510(k) numberK141009

Submission

Device name
Fort Defiance Automated Steam Sterilizer
Applicant
Fort Defiance Industries, Inc.
Loudon, TN, US
Received
April 18, 2014
Decision date
December 16, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Expedited review
Yes

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

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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
K243801FRONT-LINE Field Sterilizer (FL135)FLE · Special Fort Defiance Industries, LLC03/07/2025SE
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

More from Primus Sterilizer Company, LLC

510(k)DeviceDecision
K243801FRONT-LINE Field Sterilizer (FL135)FLE · Special 03/07/2025SE
K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries…FLE · Abbreviated 03/02/2022SE

Questions and answers

When was Fort Defiance Automated Steam Sterilizer cleared by the FDA?

Fort Defiance Automated Steam Sterilizer (K141009) received a 510(k) decision of Substantially Equivalent on December 16, 2014, 242 days after the submission was received.

What is the product code of K141009?

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