Cleared Traditional Expedited

K141009 - FORT DEFIANCE AUTOMATED STEAM STERILIZER

K141009 is an FDA 510(k) clearance for FORT DEFIANCE AUTOMATED STEAM STERILIZER, manufactured by Fort Defiance Industries, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K141009 · Fort Defiance Industries, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
242d
Days
Class 2
Risk

K141009 is an FDA 510(k) clearance for the FORT DEFIANCE AUTOMATED STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Fort Defiance Industries, Inc. (Loudon, US). The FDA issued a Cleared decision on December 16, 2014 after a review of 242 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141009

510(k) Number K141009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date December 16, 2014
Days to Decision 242 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 153
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K141009.
BELIMED STEAM STERILIZER MST-H
K141879 · Sauter AG · Jun 2015
STERISAFE HP TABLE-TOP STEAM STERILIZER
K140736 · Milton E Pedrazzi D.D.S., Inc. · Jan 2015
Pre-vacuum Tabletop Autoclave
K143311 · Tuttnauer U.S.A Co, Ltd. · Jan 2015
SAKURA STEAM STERILIZER ASSR
K132439 · Sakura Seiki Co., Ltd. · Jan 2014
BELIMED STEAM STERILIZER MST-V
K130172 · Belimed, Inc. · Sep 2013
SANICLAVE 102, MODEL RS-SC-102
K122978 · Alternative Pioneering Research and Development · May 2013