Cleared Special

K232485 - AMSCO 600 Steam Sterilizer

K232485 is the FDA 510(k) clearance for AMSCO 600 Steam Sterilizer by Steris. It is a Class 2 General Hospital device (product code FLE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K232485 · Steris · General Hospital
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Sep 2023
Decision
28d
Days
Class 2
Risk

K232485 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 (Mentor, US). The FDA issued a Cleared decision on September 13, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Steris devices

Submission Details

510(k) Number K232485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2023
Decision Date September 13, 2023
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K232485.
Lexa MINI (RIS-303, RIS-305)
K233504 · W&H Sterilization S.R.L. · Feb 2024
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · Primus Sterilizer Company, LLC · Dec 2023
T-Top 10 & T-Top T-Top 11
K232658 · Tuttnauer U.S.A Co, Ltd. · Nov 2023
Sturdy Autoclave Super Microm
K231489 · Sturdy Industrial Co., Ltd. · Jun 2023
Lexa MINI (RIS-303, RIS-305)
K223858 · W&H Sterilization S.R.L. · May 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · Primus Sterilizer Company, LLC · Feb 2023