Cleared Abbreviated

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (K213457) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K213457 · Fort Defiance Industries, LLC · General Hospital
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Mar 2022
Decision
126d
Days
Class 2
Risk

K213457 is an FDA 510(k) clearance for the Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Ind.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Fort Defiance Industries, LLC (Loudon, US). The FDA issued a Cleared decision on March 2, 2022 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Fort Defiance Industries, LLC devices

Submission Details

510(k) Number K213457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 61
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