Cleared Traditional

K183410 - AMSCO 600 Steam Sterilizer

K183410 is the FDA 510(k) clearance for AMSCO 600 Steam Sterilizer by STERIS Corporation. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K183410 · STERIS Corporation · General Hospital
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Mar 2019
Decision
107d
Days
Class 2
Risk

K183410 is an FDA 510(k) clearance for the AMSCO 600 Steam Sterilizer. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 27, 2019 after a review of 107 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 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.

View all STERIS Corporation devices

Submission Details

510(k) Number K183410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2018
Decision Date March 27, 2019
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 66
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K183410.
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MN-111
K172825 · W&H Sterilization S.R.L. · May 2018
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K173481 · STERIS Corporation · Mar 2018