Cleared Special

K112760 - AMSCO V-PRO MAX LOW TEMPERATURE STERILI...

K112760 is the FDA 510(k) clearance for AMSCO V-PRO MAX LOW TEMPERATURE STERILI... by STERIS Corporation. It is a Class 2 General Hospital device (product code MLR) cleared through the Special 510(k) pathway after a 61-day FDA review.

K112760 · STERIS Corporation · General Hospital
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Nov 2011
Decision
61d
Days
Class 2
Risk

K112760 is an FDA 510(k) clearance for the AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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 Corporation devices

Submission Details

510(k) Number K112760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2011
Decision Date November 22, 2011
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MLR Sterilizer, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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 - MLR Sterilizer, Chemical

All 42
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