Cleared Special

K233065 - V-PRO maX 2 Low Temperature Sterilizati...

K233065 is the FDA 510(k) clearance for V-PRO maX 2 Low Temperature Sterilizati... by Steris. It is a Class 2 General Hospital device (product code MLR) cleared through the Special 510(k) pathway after a 24-day FDA review.

K233065 · Steris · General Hospital
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Oct 2023
Decision
24d
Days
Class 2
Risk

K233065 is an FDA 510(k) clearance for the V-PRO maX 2 Low Temperature Sterilization System. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on October 20, 2023 after a review of 24 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 devices

Submission Details

510(k) Number K233065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date October 20, 2023
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K233065.
LOWTEM Crystal 120
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V-PRO maX 2 Low Temperature Sterilization System
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